BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
Received Jan 22, 2024 · Event occurred Jan 4, 2024
Report 3006948883-2024-00006 · MDR key 18555031
Device
Generic name
Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Catalog number
256045
Lot number
2346386
Product problems
- False Positive Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D2B: MEDICAL DEVICE TYPE: GNX & PSZ. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G5. PMA / 510(K)#: K112277, K132259, K132692, K151291, K152870, K160161. H3. 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 DURING USE, WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT A FALSE POSITIVE RESULT WAS RECEIVED FOR THE FLU A ASSAY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Description of Event or Problem
IT WAS REPORTED DURING USE, WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT A FALSE POSITIVE RESULT WAS RECEIVED FOR THE FLU A ASSAY. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING BD VERITOR¿ FLU A+B KIT (MATERIAL#: 256045), BATCH NUMBER 2346386. THE CUSTOMER REPORTED A CONTINUOUS TREND OF FALSE POSITIVE 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. NO SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, A PHOTOGRAPH WAS RETURNED AND SHOWED THE 256045 KIT LABEL AND AN 256088 KIT LABEL. 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. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.