BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12178132 · Received July 15, 2021

    Report

    Report Number
    1119779-2021-01180
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 18, 2021
    Report Date
    March 1, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER COMPLAINT ALLEGES FALSE POSITIVE OF BACTEC FX 441385 SN (B)(6). FIELD SERVICE ENGINEERING WENT ONSITE TO INVESTIGATE AND FOUND THE SOFTWARE OF THE FX TO BE OUTDATED. THIS IS A CONFIRMED FAILURE. CAPA#1233452 ADDRESSES ISSUES WITH PREVIOUS SOFTWARE VERSIONS TO STRENGTHEN THE SYSTEMS ABILITIES TO DISTINGUISH ANOMALIES/INTERFERENCE THAT ARE NOT TRUE POSITIVE SIGNALS. UPDATING THE SOFTWARE SOLVED THIS ISSUE. THERE WAS NO SAMPLE RETURNED FOR ANALYSIS, AND DEVICE HISTORY REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT ALLEGE EARLY LIFE FAILURE. NO NEW HAZARDS OR RISKS HAVE BEEN IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR FUTURE FAILURES.

    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 AND SUBCULTURE WERE 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: "CUSTOMER REPORTS SEVERAL FALSE POSITIVE RESULTS IN DRAWER A."

    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 AND SUBCULTURE WERE 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: "CUSTOMER REPORTS SEVERAL FALSE POSITIVE RESULTS IN DRAWER A."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071484 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown