BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 PZA KIT

    MDR report key: 17940859 · Received October 16, 2023

    Report

    Report Number
    1119779-2023-01127
    Event Type
    Malfunction
    Date Received
    October 16, 2023
    Date of Event
    September 25, 2023
    Report Date
    August 14, 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
    SP
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    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). A TREND FOR PERFORMANCE COMPLAINTS HAS BEEN IDENTIFIED FOR 245128 MGIT PZA KIT. BD HAS INITIATED A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) TO FORMALLY INVESTIGATE PERFORMANCE ISSUE. HOWEVER, INVESTIGATIONS HAVE NOT FOUND A DEFECT IN THE COMPLAINT KIT BATCHES (2161925 & 2032129). FOR THE PERFORMANCE DEFECT INVESTIGATIONS, RETENTION SAMPLES TESTED PER THE STANDARD PERFORMANCE PROCEDURE, WHICH IS ALSO DESCRIBED IN THE IFU (INSTRUCTIONS FOR USE, AVAILABLE ON BD.COM/E-LABELING), WERE SATISFACTORY AND HAVE NOT REPLICATED REPORTED FALSE RESISTANCE DEFECTS. THE BATCH HISTORY RECORDS WERE SATISFACTORY. RETENTION SAMPLES WERE TESTED PER THE STANDARD PERFORMANCE PROCEDURE WHICH IS ALSO DESCRIBED IN THE IFU OR RESERVED FOR FURTHER INVESTIGATIONAL TESTING FOR THE CAPA. RETENTION SAMPLE TESTING CONDUCTED FOR COMPLAINT INVESTIGATIONS HAVE NOT REPLICATED THE REPORTED DEFECT. NO PHOTOS OR RETURN SAMPLES WERE RECEIVED FOR INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE DEFECT. BD WILL CONTINUE TO TREND COMPLAINTS FOR PERFORMANCE.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2032129. D.4. MEDICAL DEVICE EXPIRATION DATE: 01-JUN-2023. H.4. DEVICE MANUFACTURE DATE: 01-FEB-2022. D.4. MEDICAL DEVICE LOT #: 2161925. D.4. MEDICAL DEVICE EXPIRATION DATE: 25-OCT-2023. H.4. DEVICE MANUFACTURE DATE: 10-JUN-2022. 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

    THE FOLLOWING UPDATES HAVE BEEN MADE: B5. 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. TWO POTENTIAL LOT NUMBERS WERE PROVIDED: D4. MEDICAL DEVICE LOT #: 2032129. D4. MEDICAL DEVICE EXPIRATION DATE: 01-JUN-2023. D4. UDI: (B)(4). H4. DEVICE MANUFACTURE DATE: 01-FEB-2022. D4. MEDICAL DEVICE LOT #: 2161925. D4. MEDICAL DEVICE EXPIRATION DATE: 25-OCT-2023. D4. UDI: (B)(4). H4. DEVICE MANUFACTURE DATE: 10-JUN-2022. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD BACTEC¿ MGIT¿ 960 PZA KIT ERRONEOUS RESULTS IN THE PYRAZINAMIDE SENSITIVITY TEST FOR MYCOBACTERIUM TUBERCULOSIS WAS OBTAINED. IT OCCURRED ON 5 SAMPLES WITH LOT# 2161925 AND ONCE WITH LOT# 2032129. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: RESULT ERROR. THE CLIENT DETECTS ERRORS IN RESULTS IN THE PYRAZINAMIDE SENSITIVITY TEST FOR MYCOBACTERIUM TUBERCULOSIS, OBTAINING A RESISTANT RESULT WHEN IN REALITY IT IS SENSITIVE CONFIRMED BY THE NATIONAL REFERENCE CENTER, THIS HAPPENED IN 5 DIFFERENT SAMPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD BACTEC¿ MGIT¿ 960 PZA KIT ERRONEOUS RESULTS IN THE PYRAZINAMIDE SENSITIVITY TEST FOR MYCOBACTERIUM TUBERCULOSIS WAS OBTAINED. IT OCCURRED ON 5 SAMPLES WITH LOT# 2161925 AND ONCE WITH LOT# 2032129. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: RESULT ERROR. THE CLIENT DETECTS ERRORS IN RESULTS IN THE PYRAZINAMIDE SENSITIVITY TEST FOR MYCOBACTERIUM TUBERCULOSIS, OBTAINING A RESISTANT RESULT WHEN IN REALITY IT IS SENSITIVE CONFIRMED BY THE NATIONAL REFERENCE CENTER, THIS HAPPENED IN 5 DIFFERENT SAMPLES.

    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
    1552146 BD BACTEC¿ MGIT¿ 960 PZA KIT SUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL MJA BECTON DICKINSON & CO. (SPARKS) SEE H.10 00382902451280

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown