BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MGIT 960 PZA

    MDR report key: 18641614 · Received February 2, 2024

    Report

    Report Number
    MW5151041
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 17, 2024
    Report Date
    January 31, 2024
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    MJA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE QC FAILURES ASSOCIATED WITH BD MGIT 960 PZA (PYRAZINAMIDE) CAUSED THE LABORATORY TO BE UNABLE TO REPORT SUSCEPTIBILITY RESULTS FOR THIS CRITICAL DRUG USED TO TREAT PATIENTS WITH MYCOBACTERIUM TUBERCULOSIS INFECTIONS. THIS IS AN ISSUE THAT HAS IMPACTED MULTIPLE OTHER PUBLIC HEALTH LABS THROUGHOUT THE COUNTRY. 2160598; 3191569; 3241654.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2092202 BD MGIT 960 PZA SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. 2160598; 3191569; 3241654

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other