BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 12021668 · Received June 17, 2021

    Report

    Report Number
    1119779-2021-01003
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 19, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MDB
    UDI-DI
    00382904413859
    PMA / PMN Number
    K915796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION FROM CUSTOMER. THE PATIENT WAS GIVEN ANTIBIOTICS DUE TO FEVER AND SYMPTOMS NOT BECAUSE OF THE FP RESULT FROM THE BACTEC VIAL..

    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 RECURRING FALSE POSITIVES. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ANALYZED THE LOG FILES WHICH REVEALED THE FLUCTUATING TEMPERATURES. THE FSE REPLACED THE COUPLING (PN# 443503 - POWER SUPPLY MAIN DC BFX SPARE), (PN# 441397 - RELAY TIMER DELAY 1 SECOND BFX SPARE) & (PN# 441320 - COUPLING SLEEVE FLEX BFX SPARE). 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 PREVIOUS COMPLAINTS FOR FALSE POSITIVES WERE OBSERVED DUE TO AMBIENT TEMPERATURES. BD QUALITY DID NOT RECEIVE ANY RETURNED PARTS OR INSTRUMENT FOR INVESTIGATION. THE ROOT CAUSE WAS WORN BLOWER COUPLING. CAPA (CORRECTIVE AND PREVENTIVE ACTION) 1233452 WAS RECENTLY IMPLEMENTED FOR FALSE POSITIVES. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE.

    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 BACTERIOSCOPY WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT UNNECESSARILY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " RECURRENCE OF FALSE POSITIVE RESULTS."

    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 BACTERIOSCOPY WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT UNNECESSARILY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " RECURRENCE OF FALSE POSITIVE RESULTS".

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(6). DEVICE EVALUATED BY MFR: 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 BACTERIOSCOPY WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT UNNECESSARILY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " RECURRENCE OF FALSE POSITIVE RESULTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913572 BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention