Customer Letter
Contents
1. confirm that the bottles are truly Negative If an Anonymous vial is removed the ID Anonymous display screen will appear and the barcode scanner will turn on All other indicator lights will turn off until the ID Anonymous workflow has been completed Note To ensure that the instrument does not lose an Anonymous vial reading please remove one vial at a time Check the status display screen following removal of each vial When an Anonymous vial is removed from the instrument perform the following steps as outlined in the User s Manual to resolve and re enter the Anonymous vial into the instrument e Scan the vial sequence barcode label e The Sequence Medium default Protocol and TIP Time in Protocol or TTD Time to Detection are automatically entered e Scan or enter the Accession number if accession barcoding is enabled e To change the protocol tap the Modify button then tap the up arrow to increase or down arrow to decrease the protocol length e lf you are returning the vial to the instrument place it in the FLASHING station station from which the vial was pulled If you are not returning the vial to the instrument tap the Save button You must do one or the other to retain the vial information e Goto the Culture display s to add the desired demographic information Note Once an Anonymous vial has been placed in the instrument do not remove the vial and re enter it without identifying it first i e fol2. Y BD Helping all people live healthy lives URGENT Field Corrective Action November 2013 Product Name Catalog Number Serial Number s BD BACTEC FX Top Unit 441385 FT2916 FT2923 FT2950 FT2956 FT2957 FT2967 FT2968 FT2992 Dear Customer BD has determined that some BD BACTEC FX instruments contain racks that may demonstrate variable indicator light intensities Specifically the Anonymous vial indicator lights which should appear yellow may instead appear more green in color Our records indicate that you may have been shipped one of the above referenced serial numbers between June 17 2013 and October 11 2013 Although unlikely this has the potential to lead to a false negative result only in the specific situation where all of the following conditions exist An Anonymous vial contains positive growth The yellow indicator light appears green The user removes Negative vials prior to resolving Anonymous vials The Anonymous vial is incorrectly interpreted as being a green end of protocol Negative vial The Anonymous vial is removed and discarded prior to completion of protocol e The user does not notice or heed the warning messages that appear on the status display touchscreen e The user does not notice the different workflow that the instrument defaults to following the removal of an Anonymous bottle compared to the workflow that the instrument enters following the removal of a Negative bottle Ple
3. ase note that affected instruments continue to function properly and will not report an incorrect result This issue is limited to the yellow indicator lights only Red and green indicator lights appear as intended BD is currently developing software to correct this issue We anticipate that the new software will be available to begin instrument updates by February 2014 The new software will not affect your instrument if the indicator lights are functioning as intended Until the software can be updated on your instrument please note the following workflow instructions to ensure that the above described situation does not occur If an ongoing Anonymous vial is removed from the instrument the ID Anonymous screen will be displayed as shown below The Negative Removal screen is also shown below for comparison A ID Anonymous Drawer A 1 Negative Removal Drawer A Accession 2 lic Removed Vial 2 lics oo Sequence 7 g 7 Accession ACC 14 e Bl 7 Medium Unknown Bio O75 Sequence 1449300000014 Qio Ol76 Status Ongoing Medium Anaerobic Flus Protocol 5 voar TIP 08 23 24 Last Location 01 A B01 TIP 00 00 09 Location 01 A A02 days hrs mins A ae gf X E ig Discard Return Rescan Save Exit Exit ID Anonymous Removal Display Negative Removal Display If Negative bottles are removed based solely on the flashing green indicator light please check the status display screen following removal of the vials to
4. low the ID Anonymous workflow described above All test readings are discarded if the Anonymous vial is removed before identifying it An alternative is to use the icon activated workflow to remove Negative vials or resolve Anonymous vials Instead of opening the drawer and pulling a vial based on the color of the flashing indicator light open the drawer and tap the Negative icon on the status display screen shown below All indicator lights will turn off except those indicating a Negative vial and the instrument will be in Negative Removal mode Similarly to resolve an Anonymous vial open the drawer and tap the Anonymous icon on the status display screen shown below All indicator lights will turn off except those indicating an Anonymous vial and the instrument will be in ID Anonymous mode The status of each vial can also be determined using the drawer view display shown below Status Reports Maintenance Configuration status Reports Maines aa Tap Negative icons on Status Display Tap Anonymous icons on Status Display screen to enter Negative Removal Screen to enter ID Anonymous workflow workflow res pe oa ieee gee Location anonymous ongoing vial anonymous positive vial red A O O O lt lt amp yellow background background s 0000000000 C O O O O O O O O O O e ongoing statuon avallaDie statuon a B D O O O O O O O O O O positive station negative station OOOO OO Os SH ble s
5. tation stati F OOOOO00000 B G O O O O O O O O O O e blocked station ws instrument because of a temperature measurement H O O O O O O O O O O Cancel or agitation failure J O O O O O00000 KOOOOOOOO0O0OO0O Drawer View Display Station Status Icons Please complete the attached form confirming your instrument serial number s so that we may acknowledge your receipt of this notification It is not necessary to contact BD by telephone regarding this matter a BD Service Representative will contact you to schedule an appointment for the software update when it becomes available lf you require further assistance or clarification please contact your local BD representative Please accept our apology for any inconvenience this situation may cause BD is committed to providing you with the highest quality products and ensuring limited impact to your lab for this particular issue Thank you for your continued support Director Regulatory Affairs and Compliance Europe BD Biosciences BD Diagnostic Systems Fax to BD Regulatory Affairs Department Fax 32 720 452 PLEASE RETURN THIS FORM SO THAT WE MAY ACKNOWLEDGE YOUR RECEIPT OF THIS NOTIFICATION Product Name Catalog Number BD BACTEC FX Top Unit 441385 Facility Please use full current facility name Please do not use initials BACTEC FX Serial Number s Contact Person Telephone
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