BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT

    MDR report key: 11933342 · Received June 3, 2021

    Report

    Report Number
    3006948883-2021-00657
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    November 25, 2020
    Report Date
    June 28, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GNX
    UDI-DI
    00382902560418
    PMA / PMN Number
    K133138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD POINT OF CARE QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING ALLEGED FALSE POSITIVE WHEN USING THE KIT FLU A+B 30 TEST HOSPITAL VERITOR (REF# 256041). BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THERE WAS NO LOT NUMBER DOCUMENTED IN THE SUBMISSION OF THIS COMPLAINT; THEREFORE NO INTERNAL INVESTIGATIONS CAN BE PERFORMED AND THE ISSUE CANNOT BE CONFIRMED. NO RETURNS WERE RECEIVED TO INVESTIGATE. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS REPORTED. IN A FOLLOW-UP, CUSTOMER INDICATED THAT THE ISSUE WAS RESOLVED BY VORTEXING THE SPECIMEN AND RUNNING THE SPECIMEN WITHOUT DELAY. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD POINT OF CARE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH FALSE POSITIVE WHEN USING THE KIT FLU A+B 30 TEST HOSPITAL VERITOR (REF# 256041). THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (17 OF 28 PATIENTS). THE RESULTS OF AN AUDIT DONE AT GERALDTON HOSPITAL SHOWS AND INCREASE IN FALSE POSITIVES WHEN CONFIRMED BY PCR OR GENE XPERT. PCR PART OF A MULTIPLEX ASSAY WHICH USES IN HOUSE REAGENTS.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED IN FACILITY DURING THIS TIME. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9091948. MEDICAL DEVICE EXPIRATION DATE: 2021-08-26. DEVICE MANUFACTURE DATE: 2019-04-01. MEDICAL DEVICE LOT #: 9210604. MEDICAL DEVICE EXPIRATION DATE: 2021-12-16. DEVICE MANUFACTURE DATE: 2019-07-29. MEDICAL DEVICE LOT #: 9239994. MEDICAL DEVICE EXPIRATION DATE: 2021-12-16. DEVICE MANUFACTURE DATE: 2019-08-27. MEDICAL DEVICE LOT #: 9259285. MEDICAL DEVICE EXPIRATION DATE: 2022-02-14. DEVICE MANUFACTURE DATE: 2019-09-16. MEDICAL DEVICE LOT #: 9324727. MEDICAL DEVICE EXPIRATION DATE: 2022-04-25. DEVICE MANUFACTURE DATE: 2019-11-20. MEDICAL DEVICE LOT #: 9324730. MEDICAL DEVICE EXPIRATION DATE: 2022-04-25. DEVICE MANUFACTURE DATE: 2019-11-20. MEDICAL DEVICE LOT #: 0041313. MEDICAL DEVICE EXPIRATION DATE: 2022-10-11. DEVICE MANUFACTURE DATE: 2020-02-10. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING WITH BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY PCR TESTING WAS PERFORMED AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (17 OF 28 PATIENTS). THE RESULTS OF AN AUDIT DONE AT GERALDTON HOSPITAL SHOWS AND INCREASE IN FALSE POSITIVES WHEN CONFIRMED BY PCR OR GENE XPERT. PCR PART OF A MULTIPLEX ASSAY WHICH USES IN HOUSE REAGENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825465 BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A + B LABORATORY KIT ANTIGENS, CF (INCLUDING CF CONTROL), INFLUENZA VIRUS A, B, C GNX BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256041 UNKNOWN 00382902560418

    Patients

    Seq Age Sex Outcome Treatment
    1