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

Description of Event or Problem

REPORT 1 OF 2. IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - CLIA WAIVED KIT, ONE (1) FALSE POSITIVE RSV PATIENT SAMPLE WAS OBTAINED. IT WAS NOTED THE POSITIVE RSV RESULT DID NOT COINCIDE WITH THE PATIENT'S MEDICAL HISTORY. CONFIRMATORY TESTING WAS PERFORMED USING PCR AND AN RSV NEGATIVE RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION: YES. D9. RETURNED TO MANUFACTURER ON: 12-AUG-2025. H3. DEVICE EVAL BY MANUFACTURER?: YES. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT RSV 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256038), BATCH NUMBER 3013644. THE CUSTOMER REPORTED THAT THEY RECEIVED AT LEAST 2 INCIDENTS OF FALSE POSITIVES. THEY RECEIVED POSITIVE RESULTS USING THE VERITOR KIT, BUT THE SAMPLES WERE TESTED WITH PCR AND HAD NEGATIVE RESULTS. 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. A PHOTO WAS RETURNED SHOWING THE KIT BOX, AND THE REPORTED ISSUE COULD NOT BE CONFIRMED THROUGH THIS IMAGE. RETURN SAMPLES WERE RECEIVED AND FUNCTIONALLY TESTED, THE RESULTS WERE PASSING AND ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

Description of Event or Problem

REPORT 1 OF 2. IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF RSV - CLIA WAIVED KIT, ONE (1) FALSE POSITIVE RSV PATIENT SAMPLE WAS OBTAINED. IT WAS NOTED THE POSITIVE RSV RESULT DID NOT COINCIDE WITH THE PATIENT'S MEDICAL HISTORY. CONFIRMATORY TESTING WAS PERFORMED USING PCR AND A RSV NEGATIVE RESULT WAS OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.