BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT
Received Jun 12, 2024 · Event occurred May 27, 2024
Report 3006948883-2024-00063 · MDR key 19524384
Device
Generic name
Antigens, Cf (including Cf Control), Influenza Virus A, B, C
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Catalog number
256045
Lot number
3229577
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
THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G.4. PMA/510(K)#: K132259, K132692, K151291, K152870, K160161. 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 WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THE CUSTOMER USED OFF LABEL PANBIO¿ COVID-19 AG TEST SWABS FOR SAMPLE COLLECTION, WHICH RESULTED IN FALSE POSITIVE RESULTS. UPON CONFIRMATORY TESTING USING PCR, THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THIS EVENT OCCURRED WITH AN UNSPECIFIED NUMBER OF SAMPLES.
Description of Event or Problem
IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT, THE CUSTOMER USED OFF LABEL PANBIO¿ COVID-19 AG TEST SWABS FOR SAMPLE COLLECTION, WHICH RESULTED IN FALSE POSITIVE RESULTS. UPON CONFIRMATORY TESTING USING PCR, THE RESULTS WERE NEGATIVE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED. THIS EVENT OCCURRED WITH AN UNSPECIFIED NUMBER OF SAMPLES.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL#: 256045), BATCH NUMBER 3229577. THE CUSTOMER REPORTED THAT THEY RECEIVED DOUBLE POSITIVE TEST RESULTS AND FLU B 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 RETURN SAMPLES WERE RECEIVED; THEREFORE, NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. THE RETURNED PHOTOGRAPH ONLY PROVIDED THE KIT INFORMATION. HOWEVER, A SUPPLEMENTAL TESTING WAS PERFORMED AND INDICATED THAT THE REPORTED ISSUE MAY OCCUR WHEN USING THE SWAB USED IN THE PANBIO¿ COVID-19 AG TEST. THE REPORTED ISSUE WAS CONFIRMED BASED ON THE SUPPLEMENTAL TEST. THE ROOT CAUSE COULD NOT BE DETERMINED. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.