BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12249182 · Received July 29, 2021

    Report

    Report Number
    1119779-2021-01241
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    February 18, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER COMPLAINED OF WITNESSING AN INCREASE IN FALSE POSITIVES WITH THEIR BACTEC FX 441385 SN: (B)(6). BD REMOTE SUPPORT REVIEWED LOG FILES AND FOUND THAT THE MACHINE WAS WORKING WITHIN SPECIFICATION, AND THAT THE AMBIENT TEMPERATURE OF THE LAB WAS LOW. HOWEVER, THIS IS A CONFIRMED FAILURE, AS THERE IS CAPA#1233452 THAT HAS BEEN IMPLEMENTED TO STRENGTHEN THE FX SOFTWARE TO DISTINGUISH OUTSIDE INTERFERENCE (SUCH AS TEMPERATURE CHANGES) FROM TRUE POSITIVE RESULTS. THIS SOFTWARE UPDATE OCCURS DURING SCHEDULED PREVENTATIVE MAINTENANCE IF NO ISSUES ARE WITNESSED. BD FIELD SERVICE ENGINEER UPDATED THE CUSTOMERS FX TO THE LATEST SOFTWARE IN AUGUST 2021. ISSUE IS RESOLVED. ROOT CAUSE IS DUE TO OUTDATED SOFTWARE. NO SAMPLE WAS RETURNED FOR ANALYSIS AND DEVICE HISTORY REVIEW WAS NOT REQUIRED AS THIS DID NOT ALLEGE AN EARLY LIFE FAILURE. NO NEW RISKS OR HAZARDS WERE IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR FUTURE FAILURES. 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 THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPSURGE IN POSITIVE VIALS".

    Additional Manufacturer Narrative · 1

    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 THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPSURGE IN POSITIVE VIALS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144605 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown