Blood Glucose Test Strip Package Insert
Contents
1. On Call Blood Glucose Test Strip Advanced Package Insert REF G134 104 English PRINCIPLE AND INTENDED USE The On Call Advanced Test Strips are thin strips with a chemical reagent system which work with the On Call Advanced Blood Glucose Meter to measure the glucose concentration in whole blood Blood is applied to the end tip of the test strip then automatically absorbed into the reaction cell where the reaction takes place A transient electrical current is formed during the reaction and the blood glucose concentration is calculated based on the electrical current detected by the meter then the result is shown on the meter display The meters are calibrated to display plasma equivalent results For in vitro diagnostic use Test strips are only to be used outside the body for testing purposes On Call Advanced Test Strips are used by people with diabetes at home and by healthcare professionals for the quantitative measurement of glucose in capillary whole blood from the finger forearm and palm It is also used as an aid in monitoring the effectiveness of diabetes control programs Professionals may also test neonatal venous and arterial blood samples COMPOSITION Each test strip contains the following reactive chemicals Glucose dehydrogenase lt 25 IU Mediator lt 300 ug Buffer Non reactive Ingredient Each test strip vial contains a drying agent TORAGE AND HANDLIN e Test strips should be stored tight2. after the expiration date shown on the vial Expired test strips may give incorrect blood glucose readings e Do not use test strips that are torn bent or damaged in any way Do not reuse test strips e Only apply the sample to the tip of the test strip Do not apply blood or control solution to the top of the test strip This may result in an inaccurate reading Check the code chip before running a blood glucose test Make sure to use the code chip that is included with that vial of strips Insert the code chip into the code chip slot The code chip slot is located on the right side of the meter e Discard the vial and any unused test strips 6 months after you first open it Constant exposure to air may destroy chemicals in the test strip This damage can cause incorrect readings Keep the test strip vial away from children and animals Consult your physician or healthcare professional before making any changes in your treatment plan based on your blood glucose test results MATERIALS PROVIDED e Test Strips e Code Chip e Package Insert MATERIALS REQUIRED BUT NOT PROVIDED e Meter e Sterile Lancets e Lancing Device e Control Solution INSTRUCTIONS FOR USE See your User s Manual for complete instructions for blood sample collection before use 1 Open the cap of the test strip vial only to remove a test strip for testing Replace the cap immediately to protect the remaining test strips from moisture in the air 2 Run the blood glucose t
3. ced Blood Glucose Monitoring System is indicated for professional use and over the counter sale Professionals may use the test strips to test capillary venous neonatal and arterial blood samples user is limited to capillary whole blood testing e Blood glucose measurement with venous or arterial blood must be performed within 15 minutes of sample collection e Anticoagulant preservatives such as heparin or EDTA are recommended for best results in using venous or arterial blood Use of anticoagulants such as iodoacetate sodium citrate or those containing fluoride is not advised e Very high above 70 and very low below 20 hematocrit can cause false results Talk to your healthcare professional to find out your hematocrit level e Abnormally high levels of Vitamin C ascorbic acid acetaminophen uric acid or other reducing substances will produce falsely high blood glucose measurements e The system is tested to accurately read the measurement of glucose in whole blood within the range of 0 6 33 3 mmol L 10 to 600 mg dL e Fatty substances Triglycerides up to 3 000 mg dL or Cholesterol up to 500 mg dL have no major effect on blood glucose test results e The On Call Advanced Blood Glucose Monitoring System has been tested and shown to work properly up to 10 000 ft 3 048 meters e Severely ill persons should not run the glucose test with the On Call Advanced Blood Glucose Monitoring System e Blood samples from patients in
4. e same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer x The results were compared in the table below Linear Regression Results On Call Advanced y vs YSI Reference x Blood Sample Slope Intercept R N Neonatal 0 9570 1 4342 0 9860 212 Arterial Study The arterial blood glucose measurements from 100 participants were taken by a trained technician using the On Call Advanced Blood Glucose Meter y The arterial blood sample from the same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer x The results were compared in the table below Linear Regression Results On Call Advanced y vs YSI Reference x Blood Sample Slope Intercept R N Arterial 1 0156 5 0976 0 9908 200 For complete instructions please refer to the On Call Advanced user s manual For additional questions or issues with this product please contact your dealer for help REFERENCES MEAN 47 6 mg dL_ 91 1 mg dL 140 2 mg dL 219 5 mg dL 360 3 mg dL 1 ADA Clinical Practice Recommendations 2003 Standard Deviation INDEX OF SYMBOLS mg dL or Coefficient of bara a 2 4 2 9 2 9 3 2 Variation CV Lli Consult instructions for bd Use by Code Intermediate Precision For in vitro diagnostic coe Ten replicate assays drawn from 3 strip lots
5. est following the instructions contained in your user s manual 3 The blood glucose test result will be shown on the meter display window This result should fall within the target range recommended by your healthcare professional If your blood glucose test results are higher or lower ask your healthcare professional what to do Always consult your healthcare professional before making any changes to your treatment plan IMPORTANT On Call Advanced Blood Glucose Monitoring System allows alternative site testing for forearm and palm testing in additional to fingertip testing There are important differences between forearm palm and fingertip samples that you should know Important information about forearm and palm glucose testing When blood levels are changing rapidly such as after a meal insulin dose or exercise blood from the fingertips may show these changes more rapidly than blood from other areas Fingertips should be used if testing is within 2 hours of a meal insulin dose or exercise and any time you feel glucose levels are changing rapidly You should test with the fingertips anytime there is a concern for hypoglycemia or you suffer from hypoglycemia unawareness RANGE OF EXPECTED VALUES Blood glucose monitoring requires the help of a healthcare professional Together you can set your own range of expected blood glucose values arrange your testing times and discuss the meaning of your blood glucose results Expected blo
6. ingertip samples were used for YSI reference measurement The sample range was 21 6 to 558 mg dL for On Call Advanced Blood Glucose Meter testing with blood sampled from fingertip sites The sample range was 79 2 to 438 mg dL for On Call Advanced Blood Glucose Meter testing with blood sampled from palm and forearm sites Fingertip Site System accuracy results for glucose concentration lt 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL 12 12 100 12 12 100 12 12 100 Fingertip Site System accuracy results for glucose concentration gt 75 mg dL Within 5 Within 10 Within 15 Within 20 155 218 71 1 211 218 96 8 217 218 99 5 218 218 100 Palm Site System accuracy results for glucose concentration lt 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL N A N A N A Palm Site System accuracy results for glucose concentration gt 75 mg dL Within 5 Within 10 Within 15 Within 20 148 210 70 5 196 210 93 3 207 210 98 6 210 210 100 Forearm Site System accuracy results for glucose concentration lt 75 mg dL Within 5 mg dL Within 10 mg dL Within 15 mg dL N A N A N A Forearm Site System accuracy results for glucose concentration gt 75 mg dL Within 5 Within 10 Within 15 Within 20 128 210 61 0 191 210 91 203 210 96 7 210 210 100 Consumer Study A consumer stud
7. ly capped in their protective vial to keep them in good working condition e Store test strips in a cool dry place at room temperature 2 30 C 36 86 F Store them away from heat and direct sunlight e Do not freeze or refrigerate e Use the test strips at room temperature This is to ensure accurate results e Do not store the test strips outside their protective vial Test strips must be stored in the original vial with the cap tightly closed e Do not store or use the test strips in a humid place such as a bathroom Do not store the meter the test strips or control solution near bleach or cleaners that contain bleach Do not transfer the test strips to a new vial or any other container Replace the vial cap immediately after removing a test strip Use the test strip immediately after removing it from the vial Do not use your test strips past the unopened expiration date printed on the vial Using test strips past the expiration date may produce incorrect test results Note All expiration dates are printed in Year Month format 2010 01 means January 2010 e Anew vial of test strips may be used for 6 months after first being opened The opened vial expiration date is 6 months after the date the vial was first opened Write the opened vial expiration date on the vial label after opening PRECAUTION e For in vitro diagnostic use The test strips are to be used only outside the body for testing purposes Do not use test strips
8. ng drugs that break down to maltose or galactose These drugs can cause inaccurate blood sugar test results due to the increase in maltose or galactose presence in the blood The following represent some drugs that may lead to false readings e Peritoneal dialysis solutions containing icodextrin e g Extraneal Icodial e Certain types of intravenous immunoglobulin therapies e g Octagam 5 e Intravenous solutions containing maltose as a means for patient hydration NOTE To determine if a drug breaks down to maltose or galactose please consult the drug package insert The list above is not meant to be an all inclusive list and may be missing other drugs e Don t use On Call Advanced Blood Glucose Monitoring System during a xylose absorption test e Blood glucose level readings may be overestimated if concentration for galactose levels gt 10 mg dL maltose levels gt 13 mg dL in the blood or lactose levels gt 5 mg dL e The meter test strips and other components have been designed tested and proven to work together effectively to provide accurate blood glucose measurements Do not use components from other brands e Do not use the meter in any manner not specified by the manufacturer Otherwise the protection provided by the meter may be impaired e The On Call Advanced Test Strips are for testing fresh capillary venous neonatal or arterial whole blood Do not use with serum or plasma samples e The On Call Advan
9. od glucose levels for people without diabetes Time Range mg dL Range mmol L Fasting and Before Meals 70 100 3 9 5 6 2 Hours After Meal Less than 140 Less than 7 8 CHECKING THE SYSTEM Your blood glucose meter must be handled carefully See your user s manual for detailed instructions for meter care The quality control test should be used to check that the meter and test strips are working together properly Follow the test procedure in your user s manual to run a quality control test Two ranges CTRL 1 and CTRL 2 are shown on the test strip vial label Control Solution 1 is sufficient for most all self testing needs If you think your meter or strips may not be working correctly you may also want to do a level 2 test Contact your dealer for information on purchasing control solution For confirmation of results Control Solution 1 tests should fall within the CTRL 1 range and Control Solution 2 tests should fall within the CTRL 2 range When testing with Control Solution 1 make sure you are matching the results to the CTRL 1 range on the vial label CAUTION If your quality control test result falls outside the control range shown on the test strip vial DO NOT use the system to test your blood as the system may not be working properly If you cannot correct the problem contact your dealer for help WARNING To avoid false readings do not use On Call Advanced Blood Glucose Monitoring System if you are taki
10. shock or with severe dehydration or from patients in a hyperosmolar state with or without ketosis have not been tested and are not recommended for testing with On Call Advanced Blood Glucose Monitoring System e Dispose of blood samples and materials carefully Treat all blood samples as if they are infectious materials Follow proper precautions and obey all local regulations when disposing of blood samples and materials PERFORMAN ARACTERISTICS Reproducibility and Precision Ten replicate assays were each run on ten On Call Advanced Blood Glucose Meters Heparinized venous blood samples at five concentration levels were used in the testing The results concluded the following reproducibility and precision estimates System Accuracy The capillary blood glucose_measurements from 115 participants were taken by a trained technician using the On Call Advanced Blood Glucose Meter y Capillary blood samples were obtained from fingertip palm and forearm sampling sites for the On Call Advanced Blood Glucose Meter testing Fingertip samples from the same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer x The results were compared in the table below Linear Regression Results On Call Advanced y vs YSI Reference x R Sample Site Slope Intercept Fingertip 0 9924 2 4070 0 9961 230 Palm 0 9826 3 0104 0 9940 210 Forearm 0 9663 5 4649 0 9889 210 F
11. were run on ten On Call Advanced Blood use only Lot Number Range Glucose Meters each day for a total of 10 days Control solutions at three concentration levels we were used in the testing The results concluded the following intermediate precision estimates A Store between 2 30 C m Manufacturer REF Catalog Standard Deviation mg dL or Y Contains sufficient for Authorized Representative in the European MEAN Coefficient of Variation CV lt n gt tests Ec REP Community 44 3 mg dL 0 8 mg dL SD Strip Lot 1 125 3 mg dL 1 8 377 8 mg dL 2 0 45 5 mg dL 1 0 mg dL SD MDSS GmbH 0197 Strip Lot 2 125 7 mg dL 1 9 ACON Laboratories Inc Schiffgraben 41 373 8 mg dL 1 7 taal 10125 Mesa Rim Road 30175 Hannover Germany 43 5 mg dL 1 2 mg dL SD San Diego CA 92121 USA Strip Lot 3 126 0 mg dL 2 29 p 3737 za 3 Number 115xxxxxx Effective Date 2010 xx xx
12. y was performed by testing three test strip lots with capillary blood sample Participants and a trained technician both used the On Call Advanced Blood Glucose Monitoring System This study showed that the patient can run the test as well as a trained technician On Call Advanced tests Linear regression of Participant versus YSI Reference value and Linear regression of Technician x versus YSI Reference value Strip Lot Test By Slope y Intercept R N Strip Lot 1 Layperson 1 0218 0 4215 0 9936 104 Strip Lot 1 Technician 0 9957 3 0506 0 9954 104 Strip Lot 2 Layperson 0 9944 2 2157 0 9931 208 Strip Lot 2 Technician 1 0031 0 9906 0 9947 208 Strip Lot 3 Layperson 0 9795 2 3250 0 9949 104 Strip Lot 3 Technician 0 9727 4 0552 0 9949 104 Venous Study The venous blood glucose measurements from 106 participants were taken by a trained technician using the On Call Advanced Blood Glucose Meter y The venous blood sample from the same subjects were also analyzed with YSI Model 2300 STAT PLUS Glucose Analyzer x The results were compared in the table below Linear Regression Results On Call Advanced y vs YSI Reference x Blood Sample Slope Intercept R N Venous 0 9900 2 189 0 9925 200 Neonatal Study The neonatal blood glucose_measurements from 106 participants were taken by a trained technician using the On Call Advanced Blood Glucose Meter y The neonatal blood sample from th
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