BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    MDR report key: 23133840 · Received September 24, 2025

    Report

    Report Number
    1119779-2025-05001
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    August 29, 2025
    Report Date
    February 18, 2026
    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

    B3. DATE OF EVENT IS UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 SIRE SUPPLEMENT KIT BATCH 4227243 IS COMPOSED OF MGIT 960 SIRE SUPPLEMENT BATCH 4172254, MGIT 960 STREPTOMYCIN BATCH 4144350, MGIT 960 ISONIAZID BATCH 4144290, MGIT 960 RIFAMPIN BATCH 4144291, AND MGIT 960 ETHAMBUTOL BATCH 4144351. MGIT 960 SIRE SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXING 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 HOMOGENEOUS 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 AN MGIT 960 SIRE SUPPLEMENT KIT (MATERIAL 245123). THE BATCH HISTORY RECORD REVIEWS FOR COMPONENT LOTS, AS WELL AS FOR THE SIRE SUPPLEMENT KIT BATCH #4227243, WERE SATISFACTORY WITH NO QUALITY NOTIFICATIONS GENERATED DURING MANUFACTURING AND INSPECTION. FORMULATION, FILLING, AND LYOPHILIZATION PROCESSES WERE WITHIN SPECIFICATIONS. QC INSPECTION AND TESTING, INCLUDING ALL STERILITY AND ANTIBIOTIC SUSCEPTIBILITY TESTING, WERE SATISFACTORY AT THE TIME OF RELEASE. THE COMPLAINT HISTORY HAS BEEN REVIEWED, AND NO OTHER COMPLAINTS WERE RECEIVED ON BATCH 4227243 FOR PERFORMANCE OR CONTAMINATION FAILURES. THERE WERE NO RETURNS RECEIVED TO ASSIST WITH THE INVESTIGATION. RETENTION SAMPLES WERE INCUBATED AT 20¿25 AND 30¿35 DEGREES CELSIUS AND INSPECTED THROUGH 14 DAYS TO ASSESS CONTAMINATION. AFTER 14 DAYS, THERE WAS NO CONTAMINATION PRESENT ON THE RECONSTITUTED DRUGS OR SUPPLEMENT VIALS. RETENTION SAMPLES WERE PERFORMANCE TESTED FOR ANTIBIOTIC SUSCEPTIBILITY PER THE BD STANDARD PERFORMANCE PROTOCOL. ALL ORGANISMS LISTED IN THE CERTIFICATE OF ANALYSIS WERE TESTED FOR ANTIBIOTIC SUSCEPTIBILITY. ANTIBIOTIC SUSCEPTIBILITY TESTING WAS SATISFACTORY WITH DETECTABLE GROWTH CONTROLS AND EXPECTED SUSCEPTIBILITY RESULTS. ONE PHOTO WAS PROVIDED FOR REVIEW. IT SHOWS A REPORT FROM A BACTEC 320 INSTRUMENT WITH GROWTH UNIT VALUES AND TUBE STATUS RESULTS FOR FIVE POSITIONS. THREE DRUG TUBES, IDENTIFIED ON THE REPORT AS ISONIAZID, RIFAMPIN, AND ONE LABELED WITH THE HANDWRITTEN NOTE ¿MOX¿, ARE MARKED AS ¿R¿ (RESISTANT). ONE DRUG TUBE, ETHAMBUTOL, IS MARKED ¿S¿ (SENSITIVE). THE FIFTH TUBE IS THE GROWTH CONTROL, LABELED ¿C.¿ NEXT TO THE GROWTH CONTROL, THE WORD ¿FLAKY¿ WAS WRITTEN AND BESIDE THE OTHER DRUG TUBES, THERE IS A HANDWRITTEN NOTE STATING ¿NO VISIBLE GROWTH RECOVERED.¿ THIS COMPLAINT COULD NOT BE CONFIRMED FOR CONTAMINATION OR PERFORMANCE DEFECTS. NO CONTAMINATION WAS OBSERVED FROM THE INCUBATED RETENTION SAMPLES, AND PERFORMANCE TESTING WITH RETENTION SAMPLES WAS SATISFACTORY. NO CONCLUSIONS COULD BE DRAWN FROM THE BACTEC 320 INSTRUMENT-UNLOADED AST SET REPORT PROVIDED FOR INVESTIGATION, AND NO RETURN SAMPLES WERE AVAILABLE. NO ADDITIONAL ACTIONS ARE INDICATED AT THIS TIME. BD WILL CONTINUE TO MONITOR TRENDS FOR PERFORMANCE AND CONTAMINATION DEFECTS.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1597592 BD BACTEC¿ MGIT¿ 960 SIRE KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON, DICKINSON & CO. (SPARKS) 4227243

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown