BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV CLIA-WAIVED KIT

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV CLIA-WAIVED KIT, A RSV POSITIVE RESULT FOR ONE (1) PATIENT WAS OBTAINED FROM A VERITOR ANALYZER. THE USER VISUALLY OBSERVED AN EXTRA LINE ON THE TEST CARTRIDGE AND QUESTIONED THE ANALYZER RESULT. THE PATIENT WAS RECOLLECTED AND A NEW SAMPLE WAS PROCESSED ON A DIFFERENT VERITOR ANALYZER WHICH PROVIDED A RSV NEGATIVE RESULT. THE USER WAS UNSURE WHICH RSV RESULT WAS CORRECT BASED ON THE EXTRA LINE OBSERVED ON THE TEST CARTRIDGE. IT IS NOTED THE PATIENT RESULT THE CUSTOMER WAS EXPECTING IS NOT KNOWN AND THERE WAS NO REPORT OF CONFIRMATORY TESTING. IT SHOULD ALSO BE NOTED THE ACTION OF VISUALLY READING A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WAS NO HEALTH IMPACT REPORTED.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION: YES. D9. RETURNED TO MANUFACTURER ON: 01-APR-2026. H3. DEVICE EVAL BY MANUFACTURER?: YES. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING KIT RSV 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256038), BATCH NUMBER 5013927. THE CUSTOMER REPORTED THAT THEY VISUALLY OBSERVED AN EXTRA LINE NOT ASSOCIATED WITH THE MARKED ANALYTES ON THE CARTRIDGE, WHEN READ WITH THE ANALYZER, THE RESULT WAS RSV POSITIVE. THEY RE-RAN THE TEST WITH ANOTHER TEST DEVICE AND THEY VISUALLY OBSERVED THE EXTRA LINES AGAIN; WHEN READ WITH THE ANALYZER, THE RESULTS WERE RSV NEGATIVE. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. PHOTOGRAPHS AND RETURN SAMPLES WERE RECEIVED. THE PHOTOGRAPHS SHOWED TWO USED TEST CARTRIDGES WITH THREE LINES: A CONTROL LINE, A TEST LINE AND THE NEGATIVE CONTROL (NC) LINE. THE NC LINE, WHICH IS UNMARKED ON THE CARTRIDGE, FUNCTIONS TO BIND WITH INTERFERING ANTIBODIES THAT MAY BE PRESENT IN A SAMPLE AND WILL REDUCE THE CHANCES OF THESE INTERFERING BODIES TO BIND TO THE OTHER TEST LINES. HOWEVER, THE REPORTED ISSUE CANNOT BE CONFIRMED THROUGH THESE IMAGES ALONE, WITHOUT ANALYZER DATA. THE RETURN SAMPLES WERE FUNCTIONALLY TESTED AND ALL RESULTS ARE PASSING AND ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV CLIA-WAIVED KIT, A RSV POSITIVE RESULT FOR ONE (1) PATIENT WAS OBTAINED FROM A VERITOR ANALYZER. THE USER VISUALLY OBSERVED AN EXTRA LINE ON THE TEST CARTRIDGE AND QUESTIONED THE ANALYZER RESULT. THE PATIENT WAS RECOLLECTED AND A NEW SAMPLE WAS PROCESSED ON A DIFFERENT VERITOR ANALYZER WHICH PROVIDED A RSV NEGATIVE RESULT. THE USER WAS UNSURE WHICH RSV RESULT WAS CORRECT BASED ON THE EXTRA LINE OBSERVED ON THE TEST CARTRIDGE. IT IS NOTED THE PATIENT RESULT THE CUSTOMER WAS EXPECTING IS NOT KNOWN AND THERE WAS NO REPORT OF CONFIRMATORY TESTING. IT SHOULD ALSO BE NOTED THE ACTION OF VISUALLY READING A TEST CARTRIDGE IS CONSIDERED OFF-LABEL USE OF THE PRODUCT. THERE WAS NO HEALTH IMPACT REPORTED.