BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 23134146 · Received September 24, 2025

    Report

    Report Number
    1119779-2025-05002
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    July 7, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    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

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 SIRE SUPPLEMENT KIT BATCH 4150973 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 4103117, MGIT 960 STREPTOMYCIN BATCH 4067432, MGIT 960 ISONIAZID BATCH 4067433, MGIT 960 RIFAMPIN BATCH 4067434 AND MGIT 960 ETHAMBUTOL BATCH 4103100. MGIT 960 SIRE SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER STANDARD OPERATING PROCEDURES (SOP). ANTIBIOTICS MGIT 960 STREPTOMYCIN, MGIT 960 ISONIAZID, MGIT 960 RIFAMPIN AND MGIT 960 ETHAMBUTOL ARE MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXING INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER SOP. EIGHT MGIT 960 SIRE SUPPLEMENT VIALS ARE THEN MANUALLY PACKAGED WITH ONE VIAL OF EACH ANTIBIOTIC TO MAKE A MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). THE BATCH HISTORY RECORD REVIEWS FOR COMPONENT LOTS, AS WELL AS FOR THE SIRE SUPPLEMENT KIT BATCH #4150973, WERE SATISFACTORY WITH NO QUALITY NOTIFICATIONS GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING AND LYOPHILIZATION PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WERE NO OTHER COMPLAINTS FOR SUSCEPTIBILITY/CONTAMINATION DEFECTS FOR BATCH 4150973. THERE WERE NO RETURNS RECEIVED TO ASSIST WITH THE INVESTIGATION. ONE PHOTO WAS RECEIVED FOR EVALUATION. THE IMAGE SHOWS A BACTEC 320 INSTRUMENT- UNLOADED AST SET REPORT WITH GROWTH UNIT AND TUBE STATUS RESULTS FOR 5 POSITIONS WITHIN THE INSTRUMENT. THE REPORT SHOWS A STATUS OF "S" FOR 3 OF THE TUBES WITH DRUG, AND A STATUS OF "R" FOR 1 OF THE TUBES WITH DRUG, AS WELL AS A POSITIVE GROWTH CONTROL. RETENTION SAMPLES OF THE SIRE SUPPLEMENT AND DRUGS WERE AVAILABLE AND TESTED FOR ANTIBIOTIC SUSCEPTIBILITY PER OUR STANDARD INSPECTION PROCEDURES. THE TEST INCLUDED 7ML MGIT, SUPPLEMENTED WITH THE SIRE SUPPLEMENT BATCH AND ISONIAZID, RIFAMPIN AND ETHAMBUTOL DRUG COMPONENTS FROM KIT 4150973, AND INOCULATED WITH MYCOBACTERIUM TUBERCULOSIS ATCC25177. TESTING WAS SATISFACTORY, WITH INHIBITED GROWTH OF ATCC25177 IN THE PRESENCE OF ALL THE DRUGS. NO SIGNS OF CONTAMINATION WERE OBSERVED WITH VISUAL INSPECTION OR WAS DETERMINED DURING TESTING. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE ISSUES AND CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) RESISTANT PATIENT RESULT TO ISONIAZID WAS OBTAINED. THE USER QUESTIONED THE RESULT DUE TO OBSERVING THE ATCC25177 GROWTH CONTROL TUBE APPEARING "FLAKY" WITH NO VISIBLE GROWTH. NO CONFIRMATORY TESTING WAS PERFORMED; HOWEVER, THE USER STATED A SUSCEPTIBLE RESULT TO ISONIAZID WAS EXPECTED. THERE WERE NO KNOWN HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) RESISTANT PATIENT RESULT TO ISONIAZID WAS OBTAINED. THE USER QUESTIONED THE RESULT DUE TO OBSERVING THE ATCC25177 GROWTH CONTROL TUBE APPEARING "FLAKY" WITH NO VISIBLE GROWTH. NO CONFIRMATORY TESTING WAS PERFORMED; HOWEVER, THE USER STATED A SUSCEPTIBLE RESULT TO ISONIAZID WAS EXPECTED. THERE WERE NO KNOWN HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850988 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 4150973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown