BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
Received Feb 24, 2021 · Event occurred Jan 29, 2021
Report 1119779-2021-00377 · MDR key 11372783
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
256056
Lot number
JB202101
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B 3 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATION TESTING WAS NOT PERFORMED. RESULTS WERE REPORTED AS NEGATIVE AS RESULTS WERE NOT CONSIDERED ACCURATE GIVEN PATIENT STATUS.
Description of Event or Problem
IT WAS REPORTED WHILE TESTING WITH BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B 3 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATION TESTING WAS NOT PERFORMED. RESULTS WERE REPORTED AS NEGATIVE AS RESULTS WERE NOT CONSIDERED ACCURATE GIVEN PATIENT STATUS.
Additional Manufacturer Narrative
H.6. INVESTIGATION: THE COMPLAINT WAS CREATED FOR SOFTWARE ISSUES ON THE BD VERITOR PLUS ANALYZER (P/N 256056, S/N (B)(6). THE CUSTOMER REPORTED THE ANALYZER GAVE FALSE POSITIVE RESULTS. THE DEVICE HISTORY RECORD FOR BD VERITOR PLUS ANALYZER, SN (B)(6), WAS EXAMINED AND SHOWED NO DISCREPANCIES RELATE TO THIS ISSUE THAT CAN BE CORRELATED TO THIS COMPLAINT. THE READER PASSED ALL TESTS INCLUDING THE FINAL ASSEMBLY PROCESS, OQA, SOURCE INSPECTION, FUNCTIONALITY, AND FINAL PACKING TEST AND MANUAL INSPECTION. THE VERITOR PLUS ANALYZER, SN (B)(6), WAS NOT RETURNED FOR INVESTIGATION AND HENCE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THEREFORE, COMPLAINT IS NOT CONFIRMED. SEE H.10.