BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 24700549 · Received March 26, 2026

    Report

    Report Number
    1119779-2026-00481
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 27, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K003062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE CUSTOMER REPORTS EVENTS OCCURRED IN 2025 AND IN 2026; HOWEVER, NO FURTHER INFORMATION CAN BE PROVIDED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4: PMA/510(K)#: K014123. 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 · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) FALSE RESISTANT M. TUBERCULOSIS PATIENT RESULT WAS OBTAINED FROM A MGIT INSTRUMENT. NO CONFIRMATORY TESTING WAS REPORTED; HOWEVER, THE CUSTOMER NOTED THAT NO ACTUAL GROWTH WAS OBSERVED. REPEAT TESTING OCCURRED AND NO ADVERSE HEALTH IMPACT WAS REPORTED. THIS IS REPORT 15 OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28728 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 5286771 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1