BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC FX TOP SERVICE CONTRACT 5 DAY

    MDR report key: 12305306 · Received August 10, 2021

    Report

    Report Number
    1119779-2021-01344
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 15, 2021
    Report Date
    March 9, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    PMA / PMN Number
    K915796A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY CUSTOMER COMPLAINT ALLEGES OF FALSE POSITIVES FOR THEIR BACTEC FX 441385 SN: (B)(6). VIALS WERE MANUALLY VERIFIED AS FALSE POSITIVE PRIOR TO TREATMENT, SO NO PATIENTS WERE AFFECTED. BD SUPPORT TEAM PULLED THE LOG FILES OF THE INSTRUMENT AND REVIEWED FOR FAILURE. THE ROOT CAUSE WAS FOUND TO BE A SOFTWARE ALGORITHM THAT TRIGGERED THE FALSE POSITIVES. BD CURRENTLY HAS ADDRESSED THIS ISSUE IN A CAPA 1233452 AND RELEASED UPDATED SOFTWARE VERSIONS. BD SUPPORT UPDATED THE MACHINE REMOTELY AND THE CASE HAS CLOSED. THIS IS A CONFIRMED COMPLAINT. DEVICE HISTORY REVIEW IS NOT APPLICABLE AS THIS DOES NOT ALLEGE AN EARLY LIFE FAILURE, AND NO SAMPLES WERE RETURNED FOR ANALYSIS. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW OR MODIFIED RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH THE FAILURE MODE DESCRIBED IN THIS COMPLAINT. H3 OTHER TEXT : SEE H10.

    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: " FALSE POSITIVE ON BACETX FX400. "

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED CATALOG NUMBER 441385 WHICH HAS 510K NUMBER K915796A.

    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: "FALSE POSITIVE ON BACETX FX400."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201962 BD BACTEC FX TOP SERVICE CONTRACT 5 DAY SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown