BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 21929400 · Received April 29, 2025

    Report

    Report Number
    1119779-2025-00315
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 8, 2025
    Report Date
    June 11, 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
    AL, 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. 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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 10-APR-2025. H3: DEVICE EVAL BY MANUFACTURER: YES. 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 CUSTOMER PROVIDED RETURNS AND MGIT 960 LAB REPORTS FOR THE INVESTIGATION. ONE (1) PZA VIAL BATCH 4060688, IN A ZIP LOCK BAG, IN A BOX WITH PAPER PADDING AND ICE PACKS. THE BATCH HISTORY RECORD WAS SATISFACTORY. RETENTION SAMPLES AND RETURN SAMPLES RECEIVED 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. 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

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, AN UNSPECIFIED NUMBER OF PZA FALSE RESISTANT PATIENT SAMPLES WERE OBTAINED. IN ADDITION, QUALITY CONTROL AND PROFICIENCY SAMPLE PZA FAILURES WERE NOTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BACTEC¿ MGIT¿ 960 PZA KIT, AN UNSPECIFIED NUMBER OF PZA FALSE RESISTANT PATIENT SAMPLES WERE OBTAINED. IN ADDITION, QUALITY CONTROL AND PROFICIENCY SAMPLE PZA FAILURES WERE NOTED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429116 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