BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12537711 · Received September 27, 2021

    Report

    Report Number
    1119779-2021-01579
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    August 23, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256082), BATCH NUMBER 1132560. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THE INVESTIGATION WAS PERFORMED ON BATCH NUMBER 1132560 AND THE COMPLAINT COULD NOT BE REPLICATED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED WITH CORRECTED INFORMATION: G.4. DATE RECEIVED BY MANUFACTURER: 2021-09-20.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE NEGATIVE".

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE NEGATIVE".

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE NEGATIVE RESULT WAS OBTAINED. REPEAT TESTS WERE PERFORMED AND THE RESULTS WERE POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE NEGATIVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430655 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1132560

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown