BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MGIT SERIES 960 AST SIRE

    MDR report key: 18376217 · Received December 21, 2023

    Report

    Report Number
    1119779-2023-01386
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 24, 2023
    Report Date
    August 14, 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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    H.6. INVESTIGATION SUMMARY: THE BATCH HISTORY RECORD REVIEWS FOR THE KIT AND EACH OF ITS COMPONENTS WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED. THE COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. RETENTION SAMPLES FROM SIRE SUPPLEMENT BATCH 3075925 (10 VIALS), STREPTOMYCIN BATCH 3075919 (10 VIALS), ISONIAZID BATCH 3075920 (10 VIALS), RIFAMPIN BATCH 3075921 (10 VIALS) AND ETHAMBUTOL BATCH 3075922 (10 VIALS) WERE AVAILABLE FOR INSPECTION. SUPPLEMENT BATCH 3095925 WAS TESTED ALONG WITH EACH OF THE KIT COMPONENT DRUGS FOR SUSCEPTIBILITY AGAINST THE ORGANISMS LISTED IN CERTIFICATE OF ANALYSIS. MGIT 7ML (MATERIAL 245122) TUBE BATCH 3103446 SAMPLES ALSO WERE AVAILABLE FOR USE IN THE TESTING INVESTIGATION. MYCOBACTERIUM TUBERCULOSIS H37RV ATCC 27294 WAS SENSITIVE TO STREPTOMYCIN BATCH 3075919, ISONIAZID BATCH 3075920, RIFAMPIN BATCH 3075921 AND ETHAMBUTOL BATCH 3075922 AS EXPECTED. MYCOBACTERIUM TUBERCULOSIS ATCC 35820 WAS RESISTANT TO STREPTOMYCIN BATCH 3075919 AS EXPECTED. MYCOBACTERIUM TUBERCULOSIS ATCC 35822 WAS RESISTANT TO ISONIAZID BATCH 3075920 AS EXPECTED. MYCOBACTERIUM TUBERCULOSIS ATCC 35838 WAS RESISTANT TO RIFAMPIN BATCH 3075921 AS EXPECTED. MYCOBACTERIUM TUBERCULOSIS ATCC 35837 WAS RESISTANT TO ETHAMBUTOL BATCH 3075922 AS EXPECTED. GROWTH CONTROLS FOR EACH ORGANISM TESTED HAD SATISFACTORY GROWTH DETECTED. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION. NO PERFORMANCE DEFECTS WERE OBSERVED FROM TESTING OF RETENTION SAMPLES OF MGIT SIRE KIT BATCH 3122877 COMPONENTS. NO PRODUCT DEFECT WAS FOUND FROM THE INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5. IT WAS REPORTED WHILE USING MGIT SERIES 960 AST SIRE, THERE WAS A LOW MIC RESULT FOR PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE MGIT SERIES 960 AST SIRE HAD A FALSE SENSITIVE. THIS EVENT OCCURRED TWO TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE MGIT SERIES 960 AST SIRE HAD A FALSE SENSITIVE. THIS EVENT OCCURRED TWO TIMES. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING MGIT SERIES 960 AST SIRE, THERE WAS A LOW MIC RESULT FOR PATIENT SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298312 MGIT SERIES 960 AST SIRE SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 3122877 00382902451235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown