BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 11363340 · Received February 22, 2021

    Report

    Report Number
    1119779-2021-00349
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 29, 2021
    Report Date
    April 29, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904419165
    PMA / PMN Number
    K915796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTIONS: D.4. DEVICE MATERIAL NUMBER: 441385; DEVICE SERIAL NUMBER: (B)(6). UDI NUMBER: (B)(4). D.2. TYPE OF DEVICE: MDB; COMMON DEVICE NAME: SYSTEM, BLOOD CULTURING. D.1. DEVICE BRAND NAME: BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED. G.5. 510K NUMBER: K915796. B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. H.4. DEVICE MANUFACTURE DATE: 2019-09-11.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AN EARLY LIFE FAILURE WAS REPORTED FALSE POSITIVE ISSUE ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N (B)(6)). NO ERRONEOUS RESULTS WERE REPORTED TO DOCTORS, AND PATIENTS WERE NOT IMPACTED. A BD FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED THAT THE PROBLEM AROSE DUE TO AN AIR CONDITIONING PROBLEM IN THE NEIGHBORING ROOM. THIS IS AN UNCONFIRMED FAILURE OF THE BD PRODUCT. REVIEW OF DEVICE HISTORY RECORD FOR (B)(6) WAS COMPLETED AND REVEALED THAT THE INSTRUMENT PASSED ALL INSPECTION TESTS AND WAS RELEASED IN GOOD CONDITION. 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 DUE TO HIGH TEMPERATURES. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE BD INSTRUMENT MAX CLINICAL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE CUSTOMER DID NOT SPECIFY WHICH ASSAYS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254113 BD BACTEC FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441916 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1