BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SYSTEM

    MDR report key: 12322107 · Received August 13, 2021

    Report

    Report Number
    1119779-2021-01383
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 23, 2021
    Report Date
    January 31, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904458706
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS COMPLAINT ALLEGES FALSE NEGATIVE RESULTS ON A MGIT 960 INSTRUMENT (P/N 445870, S/N (B)(6). THE CUSTOMER REPORTED MULTIPLE FALSE NEGATIVE RESULTS ON THEIR INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER SITE AND NOTED MULTIPLE ISSUES THAT COULD CONTRIBUTE TO THE FALSE RESULTS. LOG FILES SHOWED POWER SURGES IN THE LABORATORY THAT CONTRIBUTED TO DRAWERS A,B AND C GOING OFFLINE. LOGS ALSO SHOW CONSTANT HIGH TEMPERATURES IN THE LABORATORY. IT IS RECOMMENDED BY THE FSE TO RESOLVE TEMPERATURE ISSUES AND POWER ISSUES. NO SAMPLES OR PARTS WERE EXPECTED TO BE RETURNED FOR THIS COMPLAINT AND THUS, RETURNED SAMPLE ANALYSIS IS NOT REQUIRED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. DEVICE WAS INSTALLED 2013. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. THIS COMPLAINT IS UNCONFIRMED AS AN INSTRUMENT ISSUE WAS NOT IDENTIFIED. COMPLAINT HISTORY FOR RESULTS WAS REVIEWED FOR THE MONTH OF JULY. THE UPPER CONTROL LIMIT WAS NOT BREACHED, AND TRENDS WERE NOT IDENTIFIED ASSOCIATED WITH THIS DEFECT. CAPA IS NOT REQUIRED AS NO TRENDS WERE IDENTIFIED, AND THIS COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A VERIFICATION TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " RECURRENT PROBLEMS OF RELEASE BY MGIT OF NEGATIVE SAMPLE WITH VERIFICATION OF BACILLI IN SLIDE AND SUBSEQUENT GROWTH IN LJ, SEEDED WITH THE SEDIMENT COMING FROM THE "NEGATIVE" MGIT."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MGIT¿ 960 SYSTEM FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A VERIFICATION TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE NOT REPORTED OUT SO THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECURRENT PROBLEMS OF RELEASE BY MGIT OF NEGATIVE SAMPLE WITH VERIFICATION OF BACILLI IN SLIDE AND SUBSEQUENT GROWTH IN LJ, SEEDED WITH THE SEDIMENT COMING FROM THE "NEGATIVE" MGIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214958 BD BACTEC¿ MGIT¿ 960 SYSTEM SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 445870 00382904458706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown