BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 20623843 · Received November 6, 2024

    Report

    Report Number
    1119779-2024-00814
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    September 20, 2024
    Report Date
    June 4, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 - 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). THE BATCH HISTORY RECORD WAS SATISFACTORY. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING) OR RESERVED FOR FURTHER INVESTIGATIONAL TESTING INTO THIS ISSUE. RETENTION SAMPLE TESTING CONDUCTED FOR INVESTIGATION HAS REPLICATED THE FALSE RESISTANCE DEFECT. SIX PHOTOS WERE RECEIVED WITH THIS COMPLAINT. ONE PHOTO SHOWED A BACTEC REPORT. FIVE REPEATED PHOTOS SHOWED KIT CARTON LABEL BATCH 4150998. THIS COMPLAINT IS CONFIRMED. A TREND IN PERFORMANCE COMPLAINTS HAS BEEN IDENTIFIED FOR 245128 MGIT PZA KIT. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE THE PERFORMANCE ISSUE. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Description of Event or Problem · 0

    REPORT 1 OF 2. IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, ONE (1) PATIENT PZA FALSE RESISTANT RESULT WAS OBTAINED, ALONG WITH FAILED PZA FALSE RESISTANT QC. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT AND TESTING IS BEING REPROCESSED USING A DIFFERENT KIT BATCH NUMBER. PATIENT RESULTS ARE DELAYED; HOWEVER, THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 1 OF 2. IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, ONE (1) PATIENT PZA FALSE RESISTANT RESULT WAS OBTAINED, ALONG WITH FAILED PZA FALSE RESISTANT QC. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT AND TESTING IS BEING REPROCESSED USING A DIFFERENT KIT BATCH NUMBER. PATIENT RESULTS ARE DELAYED; HOWEVER, THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998992 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) 4150998 00382902451280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown