BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM YELLOW COLOR BUFFER WAS OBSERVED AND INVALID RESULTS WHEN STRIPS WERE USED. THIS OCCURRED 14 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COSTUMER OBSERVED YELLOW-COLORED BUFFERS IN THE REAGENT STRIPS OF THE RVP ASSAY FOR BD MAX. IN PARALLEL THE CUSTOMER OBSERVED SOMETIMES INVALIDED RESULTS, WHEN THESE STRIPS WERE USED. IN TOTAL 14 STRIPS WERE COUNTED.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR UNUSUAL COLOR BUFFERS IN UNITIZED REAGENT STRIP (URS) AND INVALID RESULTS WHEN USING THE BD RESPIRATORY VIRAL PANEL FOR BD MAX SYSTEM KIT (REF. (B)(4)) LOT 2229196 WAS PERFORMED BY THE REVIEW OF THE MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, VISUAL INSPECTION OF RETURNED PHOTOGRAPHIC EVIDENCE AND BY THE COMPLAINT¿S HISTORY REVIEW. REVIEW OF THE MANUFACTURING RECORDS OF BD RESPIRATORY VIRAL PANEL FOR BD MAX SYSTEM KIT INDICATED THAT THE KITS WERE ASSEMBLED USING AN AUTOMATED PROCESS AND THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND MET PERFORMANCE REQUIREMENTS. THE RETAIN MATERIAL OF BD RESPIRATORY VIRAL PANEL FOR BD MAX SYSTEM KIT FROM LOT 2229196 WAS VISUALLY INSPECTED AND TESTED. ALL THE URS SHOWED CLEAR BUFFERS AND CONFORMING VOLUMES AND ALL THE REACTIONS TESTED GAVE RESULTS AS EXPECTED. OVERALL, RETAIN MATERIAL INSPECTION AND TESTING WAS AS EXPECTED. CUSTOMER OBSERVED YELLOW-COLORED BUFFERS IN UNITIZED REAGENT STRIP (URS) FOR BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT LOT 2229196. IN PARALLEL, THE CUSTOMER OBSERVED SOME INVALID RESULTS WHEN THESE STRIPS WERE USED. ONE PICTURE WAS RECEIVED FOR INVESTIGATION, SHOWING A BOTTOM VIEW OF A THERMOFORM WITH FIVE OF TWELVE URS IDENTIFIED. BASED ON THE PICTURE, THESE URS ALL APPEAR TO HAVE COLORED BUFFERS, CONFIRMING THE CUSTOMER ISSUE. THIS ISSUE MAY OCCUR IF BUFFERS ARE MIXED. HOWEVER, THE PICTURES PROVIDED DO NOT ALLOW TO SEE BUFFERS VOLUME OR STRIP SEALING, WHICH COULD HAVE HELPED EXPLAIN THE ISSUE. CUSTOMER MENTIONED THAT 14 URS WERE CONCERNED AND SOMETIMES, INVALID RESULTS WERE OBTAINED. HOWEVER, NO DATA WAS PROVIDED, AND THE INVESTIGATION WAS LIMITED. BASED ON THE AVAILABLE INFORMATION, BD WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE CUSTOMER ISSUE, BUT IT APPEARS TO HAVE BEEN ISOLATED. THERE IS NO INDICATION OF URS WITH UNUSUAL COLOR BUFFERS ISSUE AND INDETERMINATE RESULTS BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED ON BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM KIT LOT 2229196. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD WAS IDENTIFIED. BD APOLOGIZES FOR THE INCONVENIENCE THAT THIS MAY HAVE CAUSED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

INITIAL REPORTER FACILITY NAME: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD RESPIRATORY VIRAL PANEL FOR BD MAX¿ SYSTEM YELLOW COLOR BUFFER WAS OBSERVED AND INVALID RESULTS WHEN STRIPS WERE USED. THIS OCCURRED 14 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COSTUMER OBSERVED YELLOW-COLORED BUFFERS IN THE REAGENT STRIPS OF THE RVP ASSAY FOR BD MAX. IN PARALLEL THE CUSTOMER OBSERVED SOMETIMES INVALIDED RESULTS, WHEN THESE STRIPS WERE USED. IN TOTAL 14 STRIPS WERE COUNTED.