BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 22555122 · Received July 21, 2025

    Report

    Report Number
    1119779-2025-01773
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 23, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451235
    PMA / PMN Number
    K003062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 REVIEW FOR THE KIT AND COMPONENT LOTS WAS 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 "FALSE RESISTANCE" DEFECTS FOR BATCH 4150973. THERE ARE NO RETURNS AVAILABLE TO ASSIST WITH THE INVESTIGATION. RETENTION SAMPLES OF THE SIRE SUPPLEMENT AND DRUGS WERE AVAILABLE AND TESTED FOR ANTIBIOTIC SUSCEPTIBILITY PER OUR STANDARD INSPECTION PROCEDURES AS DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE) FOR THIS PRODUCT (AVAILABLE ON BD.COM/E-LABELING). 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. THIS COMPLAINT CANNOT BE CONFIRMED. NO COMPLAINT TRENDS HAVE BEEN IDENTIFIED FOR THIS PRODUCT. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE ISSUES.

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. INITIAL REPORTER PHONE #:(B)(6). E1. INITIAL REPORTER FACILITY NAME: (B)(6). 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 WHEN USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) SAMPLE RUN RESULTED AS FALSE RESISTANT TO ISONIAZID AND RIFAMPICIN. THE PATIENT'S GENOTYPE TESTING SHOWED NO RESISTANCE TO ISONIAZID OR RIFAMPICIN. IN ADDITION, THE SAMPLE WAS SENT TO THE NATIONAL REFERENCE CENTRE OF MYCOBACTERIA FOR CONFIRMATORY RESISTANCE TESTING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 SIRE KIT, ONE (1) SAMPLE RUN RESULTED AS FALSE RESISTANT TO ISONIAZID AND RIFAMPICIN. THE PATIENT'S GENOTYPE TESTING SHOWED NO RESISTANCE TO ISONIAZID OR RIFAMPICIN. IN ADDITION, THE SAMPLE WAS SENT TO THE NATIONAL REFERENCE CENTRE OF MYCOBACTERIA FOR CONFIRMATORY RESISTANCE TESTING. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2726193 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 4150973 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown