BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 20044196 · Received August 22, 2024

    Report

    Report Number
    1119779-2024-00624
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 14, 2025
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    MJA
    UDI-DI
    00382902451280
    PMA / PMN Number
    K021582
    Removal / Correction Number
    Z-2686-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT#: 4051247. D.4. MEDICAL DEVICE EXPIRATION DATE: 16-JUL-2025. H.4. DEVICE MANUFACTURE DATE: 20-FEB-2024. D.4. MEDICAL DEVICE LOT#: 3304389. D.4. MEDICAL DEVICE EXPIRATION DATE: 26-MAR-2025. H.4. DEVICE MANUFACTURE DATE: 31-OCT-2023. D.4. MEDICAL DEVICE LOT#: 4036330. D.4. MEDICAL DEVICE EXPIRATION DATE: 19-JUN-2025. H.4. DEVICE MANUFACTURE DATE: 05-FEB-2024. E.1. INITIAL ADDR 1: (B)(6). 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 FOR BATCHES 3304389, 4036330, AND 4051247. ADDITIONALLY, 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 COMPLAINT INVESTIGATIONS HAVE NOT REPLICATED REPORTED DEFECT. THIS COMPLAINT IS CONFIRMED. TREND IN PERFORMANCE COMPLAINTS 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 4051247. B5. IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WERE AN UNKNOWN NUMBER OF FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, AN UNSPECIFIED NUMBER OF FALSE RESISTANT PZA PATIENT RESULTS WERE OBTAINED WHEN COMPARED WITH GENOME SEQUENCING TESTING RESULTS. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ MGIT¿ 960 PZA KIT, THERE WERE AN UNKNOWN NUMBER OF FALSE RESISTANT RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071058 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) SEE H.11 00382902451280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown