BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12594938 · Received October 7, 2021

    Report

    Report Number
    1119779-2021-01622
    Event Type
    Malfunction
    Date Received
    October 7, 2021
    Date of Event
    September 10, 2021
    Report Date
    March 30, 2022
    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

    INVESTIGATION SUMMARY: CUSTOMER REPORTED AN ISSUE ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, (B)(6) ). CUSTOMER INDICATED ABOUT THE FALSE POSITIVES. NO ERRONEOUS RESULTS WERE REPORTED TO DOCTORS, AND PATIENTS WERE NOT IMPACTED. BD REMOTE ASSISTANCE COMMUNICATED WITH THE CUSTOMER REMOTELY AND UPGRADED THE SOFTWARE TO V6.40. THIS IS A CONFIRMED FAILURE OF THE BD PRODUCT. REVIEW OF DEVICE HISTORY RECORD FOR THIS INSTRUMENT 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 ON 10/2/2014. SERVICE HISTORY REVIEW WAS PERFORMED FOR THIS INSTRUMENT AND NO ADDITIONAL WORK ORDERS WERE OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION. IF SAMPLES ARE RECEIVED AT A LATER DATE, THE COMPLAINT MAY BE REOPENED. THE ROOT CAUSE WAS SOFTWARE ISSUE. CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1233452 WAS RECENTLY IMPLEMENTED FOR FALSE POSITIVES. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGE PRODUCED A FALSE POSITIVE RESULT. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD CULTURE FALSE POSITIVES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGE PRODUCED A FALSE POSITIVE RESULT. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD CULTURE FALSE POSITIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488692 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED BLOOD CULTURING SYSTEM MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown