BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT

    MDR report key: 15513649 · Received September 30, 2022

    Report

    Report Number
    3014704491-2022-00453
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    September 19, 2022
    Report Date
    November 29, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    GNX
    UDI-DI
    00382902560456
    PMA / PMN Number
    K132692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER 0310032 / 0304672. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION WAS PERFORMED AS ON THE BATCH NUMBER PROVIDED. THE RETAIN TEST FOR BOTH BATCHES (0310032 AND 0304672) DID NOT IDENTIFY ANY ISSUES, RESULTS WERE ACCEPTABLE. THE RETURN SAMPLE TEST DEMONSTRATED THE ASSAY WAS WORKING AS INTENDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THERE ARE NO CURRENT TRENDS AGAINST FALSE POSITIVE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT RECEIVED FP FLU A RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER RECEIVED FP FLU A RESULTS. WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? SAW TREND, TESTED ASYMPTOMATIC EMPLOYEES IN OFFICE, ALSO RAN TESTS WITHOUT SWABBING PERSON, STILL CAME POSITIVE (KIT LOT #0304672 USED) . 3 PATIENT TESTS CONFIRMED VIA PCR NEGATIVE (KIT LOT # 0310032 USED). WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES (KIT LOT # 0310032 USED). IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? APPROXIMATELY 12 PATIENTS TREATED (KIT LOT # 0310032 USED). IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO (KIT LOT # 0310032 USED).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT RECEIVED FP FLU A RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER RECEIVED FP FLU A RESULTS. WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? SAW TREND, TESTED ASYMPTOMATIC EMPLOYEES IN OFFICE, ALSO RAN TESTS WITHOUT SWABBING PERSON, STILL CAME POSITIVE (KIT LOT #0304672 USED) . 3 PATIENT TESTS CONFIRMED VIA PCR NEGATIVE (KIT LOT # 0310032 USED). WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES (KIT LOT # 0310032 USED). IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? APPROXIMATELY 12 PATIENTS TREATED (KIT LOT # 0310032 USED). IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO. (KIT LOT # 0310032 USED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826298 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAVED KIT ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C GNX BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 256045 0310032 00382902560456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention