BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 11787232 · Received May 6, 2021

    Report

    Report Number
    1119779-2021-00782
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 12, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER REPORTED AN ISSUE ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N (B)(6). CUSTOMER INDICATED ABOUT THE FALSE POSITIVES. BD REMOTE ASSISTANCE COMMUNICATED WITH THE CUSTOMER AND UPGRADED THE SOFTWARE TO V6.40A. THE INSTRUMENT IS DEEMED FUNCTIONAL AND HANDED OVER TO THE CUSTOMER FOR USE. THIS IS A CONFIRMED FAILURE OF THE BD PRODUCT. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS SOFTWARE ISSUE. CAPA 1233452 WAS RECENTLY IMPLEMENTED FOR FALSE POSITIVES. NO NEW RISKS OR HAZARDS. NO NEW TRENDS AFTER TAKING THE UNCONFIRMED COMPLAINTS INTO ACCOUNT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FALSE POSITIVE A SUB-CULTURE AND/OR GRAM STAIN MIGHT BE PERFORMED. AND NO ERRONEOUS RESULT WAS REPORTED TO THE DOCTOR. FE COLLECTED LOG FILE AND CONFIRMED THE ERROR, BUT CAUSE WAS UNDETERMINED. THE INSTRUMENT WORK NORMALLY WITHOUT ANY ADJUSTMENT NOR REPLACEMENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " FALSE POSITIVE. A SUB-CULTURE AND/OR GRAM STAIN MIGHT BE PERFORMED. AND NO ERRONEOUS RESULT WAS REPORTED TO THE DOCTOR. FE COLLECTED LOG FILE AND CONFIRMED THE ERROR, BUT CAUSE WAS UNDETERMINED. THE INSTRUMENT WORK NORMALLY WITHOUT ANY ADJUSTMENT NOR REPLACEMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680169 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown