BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 24700530 · Received March 26, 2026

    Report

    Report Number
    1119779-2026-00469
    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 9 OF 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5574 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 5286771 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown