BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 11787156 · Received May 6, 2021

    Report

    Report Number
    1119779-2021-00780
    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
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER REPORTED AN ISSUE ON A REMANUFACTURED BD BACTEC FX TOP INSTRUMENT (P/N 441676, (B)(6) ). CUSTOMER INDICATED ABOUT THE FALSE POSITIVES IN ROWS C\D OF DRAWER A. NO ERRONEOUS RESULTS WERE REPORTED TO DOCTORS, AND PATIENTS WERE NOT IMPACTED. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED (441452 - KIT BLOWER COUPLING BFX SPARE). 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 A PREVIOUS COMPLAINT FOR FALSE POSITIVE ISSUE FOR. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS BLOWER MOTOR FAILURE. 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. H3 OTHER TEXT : SEE H.10.

    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. A GRAM STAIN 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: " DESC INCREASE IN FALSE POSITIVE CONFIRMED VIA GRAM. ERRONEOUS RESULTS: YES. DETAILED ERRONEOUS RESULTS: CONFIRM VIA GRAM NO INCIDENCE ON PATIENT".

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: UNKNOWN. 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¿ FX, INSTRUMENT TOP, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A GRAM STAIN 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: "DESC INCREASE IN FALSE POSITIVE CONFIRMED VIA GRAM. ERRONEOUS RESULTS: YES. DETAILED ERRONEOUS RESULTS CONFIRM VIA GRAM NO INCIDENCE ON PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682336 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown