BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12046023 · Received June 22, 2021

    Report

    Report Number
    1119779-2021-01032
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 27, 2021
    Report Date
    December 17, 2021
    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

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER REPORTED AN ISSUE ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N (B)(6)). CUSTOMER INDICATED ABOUT THE FALSE POSITIVES. A BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND UPDATED SOFTWARE TO 6.40 ON FX AND RECONNECTED TO EPICENTER. THE INSTRUMENT IS DEEMED FUNCTIONAL AND HANDED OVER TO THE CUSTOMER FOR USE. THIS IS A CONFIRMED FAILURE OF THE BD PRODUCT. DHR REVIEW IS NOT REQUIRED FOR THIS COMPLAINT AS THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR THIS ISSUE. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS OUTDATED SOFTWARE. NO NEW RISKS OR HAZARDS. NO NEW TRENDS AFTER TAKING THE UNCONFIRMED COMPLAINTS INTO ACCOUNT. CAPA#1233452 WAS RECENTLY IMPLEMENTED FOR FALSE POSITIVES. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED A FALSE POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORT OF CONFIRMATORY TESTING OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936314 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