BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12268075 · Received August 3, 2021

    Report

    Report Number
    3006948883-2021-00860
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 6, 2021
    Report Date
    September 23, 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
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS IS TO SUMMARIZE THE INVESTIGATION RESULTS FOR CUSTOMER COMPLAINTS ALLEGING FALSE POSITIVE OR DISCREPANT RESULTS WHEN USING THE KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041) BATCH NUMBER 0040169. 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 AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING FOR FLU A WITH BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. RESULT WAS REPORTED TO DOCTOR. THERE WAS NO PATIENT IMPACT. (2 OF 2 PATIENTS) IT WAS REPORTED THAT CUSTOMER IS GETTING FALSE POSITIVE RESULT FOR FLU A WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? PCR. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: PATIENTS BIRTHDAY WAS NOT PROVIDED, (B)(6) 2020 WAS USED BASED ON AGE OF PATIENT. 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 · 1

    IT WAS REPORTED THAT WHILE TESTING FOR FLU A WITH BD VERITOR" SYSTEM FOR RAPID DETECTION OF FLU A+B LABORATORY KIT A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. RESULT WAS REPORTED TO DOCTOR. THERE WAS NO PATIENT IMPACT. (2 OF 2 PATIENTS) IT WAS REPORTED THAT CUSTOMER IS GETTING FALSE POSITIVE RESULT FOR FLU A WHAT CONFIRMATORY TESTING WAS PERFORMED THAT DETERMINED THE RESULTS WERE ERRONEOUS? PCR. WERE ANY ERRONEOUS RESULTS REPORTED TO THE DOCTORS? YES. IF YES, WERE ANY PATIENTS TREATED BASED ON ERRONEOUS RESULTS? NO. IF YES, DID THE ERRONEOUS TREATMENT HAVE ANY ADVERSE IMPACT TO THE PATIENT(S)? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163202 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 0040169 00382902560418

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR