BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12197707 · Received July 20, 2021

    Report

    Report Number
    1119779-2021-01204
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 24, 2021
    Report Date
    January 24, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : CUSTOMER REPORTED AN ISSUE ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N (B)(6). CUSTOMER INDICATED ABOUT THE FALSE POSITIVES. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED (441735 - SYSTEM CONTROLLER MODULE BFX SPARE) FOLLOWED BY RE-IMAGING THE INSTRUMENT AND SOFTWARE UPGRADE TO VERSION 6.40. THE INSTRUMENT IS DEEMED FUNCTIONAL AND HANDED OVER TO THE CUSTOMER FOR USE. THIS IS A CONFIRMED FAILURE OF THE BD PRODUCT. DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED FOR THIS COMPLAINT. THE COMPLAINT WAS EVALUATED VIA OTHER ELEMENTS OF THE INVESTIGATION. THE RESULTS OF THIS EVALUATION HAVE NOT IDENTIFIED ANY NEW HAZARDS, NEW RISKS, OR SPECIFIC TRENDS. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINT FOR FALSE POSITIVE ISSUE. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS SOFTWARE ISSUE AND FAULTY CPU. CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1233452 WAS RECENTLY IMPLEMENTED FOR FALSE POSITIVES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED 11 FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 11 FALSE POSITIVES.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED 11 FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS 11 FALSE POSITIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092992 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 NA 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown