BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 13081247 · Received December 23, 2021

    Report

    Report Number
    1119779-2021-02028
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    October 24, 2021
    Report Date
    March 4, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE RESULT 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 ON THE BATCH NUMBER PROVIDED. A BATCH HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. NO CUSTOMER SAMPLES WERE RETURNED FOR TESTING AND RETENTION TESTING WAS NOT PERFORMED AS THE BATCH IS EXPIRED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED, AND ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE NEGATIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS POSITIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. (B)(6) 2021 (DATE) - WHAT EXACT TIME DID YOU READ THE FALSE NEGATIVE RESULT WHEN PERFORMING THE SARS COV-2 TEST KIT (REF # (B)(4) - LOT #1152035) EUA#:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 FALSE NEGATIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS POSITIVE. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. (B)(6) 2021 (DATE) - WHAT EXACT TIME DID YOU READ THE FALSE NEGATIVE RESULT WHEN PERFORMING THE SARS COV-2 TEST KIT (REF # (B)(4) - LOT #1152035). EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970370 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1152035

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown