BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 22912635 · Received August 28, 2025

    Report

    Report Number
    1119779-2025-04505
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    October 10, 2023
    Report Date
    July 8, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451280
    PMA / PMN Number
    K021582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MGIT 960 PZA KIT BATCH 2160583 IS COMPOSED OF MGIT PZA BATCH 2110643 AND MGIT 960 PZA SUPPLEMENT BATCH 2095099. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 PZA KIT BATCH 2160583 WAS SATISFACTORY. NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS BATCH FOR CONTAMINATION. OTHER COMPLAINTS HAVE BEEN TAKEN FOR PERFORMANCE BUT ARE ALSO NOT CONFIRMED. BACTEC MGIT 960 PZA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). BACTEC MGIT 960 PZA 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 SOP. TWO BACTEC MGIT 960 PZA VIALS ARE THEN MANUALLY PACKAGED WITH SIX BACTEC MGIT 960 PZA SUPPLEMENT VIALS TO COMPLETE A BACTEC MGIT 960 PZA KIT (MATERIAL 245128). BATCH HISTORY RECORD REVIEWS FOR MGIT PZA BATCH 2110643 AND MGIT 960 PZA SUPPLEMENT BATCH 2095099 WERE SATISFACTORY, AND NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE FOR BOTH PRODUCTS. THE RELEASE TESTING THAT IS PERFORMED ON THIS PRODUCT DOES INCLUDE BIOBURDEN TESTING. SAMPLES ARE INCUBATED AT 25 DEGREES C AND AT 35 DEGREES C FOR 14 DAYS. ALL BIOBURDEN TESTING PERFORMED ON THIS BATCH WAS SATISFACTORY PER OUR INTERNAL PROCEDURES. RETENTION SAMPLES FROM MGIT PZA BATCH 2110643 (8 VIALS) AND PZA SUPPLEMENT BATCH 2095099 (8 VIALS) WERE AVAILABLE FOR INSPECTION. NO MICROBIAL GROWTH WAS OBSERVED IN 8/8 RETENTION VIALS OF PZA SUPPLEMENT BATCH 2095099 AND 8/8 RETENTION VIALS OF PZA BATCH 2110643. FOR INVESTIGATION, TWO VIALS OF PZA BATCH 2110643 WERE RECONSTITUTED WITH 2.5ML OF STERILE WATER. ONE RECONSTITUTED VIAL OF PZA BATCH 2110643 AND ONE PZA SUPPLEMENT VIAL FROM BATCH 2095099 WERE INCUBATED AT 20 TO 25 DEGREES C AND ONE RECONSTITUTED PZA VIAL AND ONE PZA SUPPLEMENT VIAL WERE INCUBATED AT 33 TO 37 DEGREES C. AT 14 DAYS INCUBATION, 0/4 VIALS HAD MICROBIAL GROWTH. THE RETENTION SAMPLES ALSO WERE PERFORMANCE TESTED FOR SUSCEPTIBILITY PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE PRODUCT INSERT AND INCLUDES MYCOBACTERIUM TUBERCULOSIS SUBSP. TUBERCULOSIS H37RV ATCC 27294. ATCC 27294 IS EXPECTED TO BE SENSITIVE TO PZA. ALL PERFORMANCE TESTING WAS SATISFACTORY PER PROCEDURES, INCLUDING SENSITIVITY FOR ATCC 27294 AS EXPECTED. NO RETURN SAMPLES OR PHOTOS WERE RECEIVED FOR INVESTIGATION OF THIS COMPLAINT. THIS COMPLAINT CANNOT BE CONFIRMED FOR CONTAMINATION. PERFORMANCE TESTING OF THE RETENTION SAMPLES WAS SATISFACTORY. THIS COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE DEFECT. IT IS NOTED THAT A PERFORMANCE DEFECT FOR MGIT PZA KIT MATERIAL 245128 WAS NOT FOUND. DURING INVESTIGATION, BD RESEARCH AND DEVELOPMENT WAS CONSULTED ABOUT POSSIBLE FALSE RESISTANCE RESULTS WITH PZA AND MYCOBACTERIUM TUBERCULOSIS ORGANISMS EXPECTED TO BE SENSITIVE LIKE ATCC 27294. THE TEAM FOUND THIS INVESTIGATION APPROPRIATE BUT EXPRESSED CONCERN WITH MYCOBACTERIUM TUBERCULOSIS ORGANISMS MAINTAINED FOR QC TESTING SWITCHING RESISTANCE TO PZA. A SUGGESTION FOR WIDENED TROUBLESHOOTING WAS MADE, SPECIFICALLY AROUND THE CULTURING AND MAINTENANCE OF TEST ORGANISMS (INCLUDING ANY BD REAGENTS NEEDED TO DO SO). IT IS POSSIBLE FOR MYCOBACTERIUM TUBERCULOSIS ORGANISMS TO HAVE MORE HOMOGENOUS GROWTH WHICH PRODUCES A HIGH BIOMASS AND RESULTS IN A HIGHER INOCULUM THAN INTENDED AFTER DILUTION FOR TESTING. BD IS NOT SUGGESTING THIS A ROOT CAUSE FOR EXPERIENCES OF FALSE RESISTANCE OF MYCOBACTERIUM TUBERCULOSIS WITH PZA. THIS IS A SUGGESTION FOR TROUBLESHOOTING ONLY. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION AND PERFORMANCE DEFECTS. THIS 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 WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WAS AN INCORRECT PYRAZINAMIDE SENSITIVITY RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2742510 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 2160583 00382902451280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown