BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12565179 · Received October 1, 2021

    Report

    Report Number
    3006948883-2021-00952
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 5, 2021
    Report Date
    September 7, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR CE (MATERIAL # 256089), BATCH NUMBER 1091111. 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. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TESTING FOR SARS COV-2, 3 FALSE POSITIVE RESULTS FROM THE SAME PATIENT WERE PRODUCED BY THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2. CONFIRMATORY TESTING WAS DONE ON THREE SEPARATE PCR SYSTEMS: BIOFIRE, GENEXPERT AND SEEGENE, BUT THE POSITIVE RESULTS COULD NOT BE CONFIRMED. RESULTS WERE REPORTED TO CLINICIANS AS THE PATIENT WAS A FELLOW STAFF MEMBER; HOWEVER, THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A STAFF MEMBER... WAS DETECTED AS SARS-COV-2 POSITIVE BY THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2, 30 TEST. THIS HAPPENED 3 CONSECUTIVE TIMES FOR THE SAME PATIENT ALTHOUGH THE POSITIVE RESULTS COULD NOT BE CONFIRMED BY 3 DIFFERENT PCR SYSTEMS: BIOFIRE, GENEXPERT AND SEEGENE. PROF.... SAID THAT THEY COULD SEE CLEARLY TWO LINES IN THEIR DESIGNATED PLACES ON THE CARTRIDGE: T AND C, NO ODD COLOURING PATTERN SUCH AS SMEARS OR DOTS WERE OBSERVED AND INSTRUMENT INTERPRETATION WAS "SARS-COV-2 +" ON ALL 3 CASES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461404 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1091111

    Patients

    Seq Age Sex Outcome Treatment
    1