BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC FX, INSTRUMENT TOP, PACKAGED

    MDR report key: 11708748 · Received April 22, 2021

    Report

    Report Number
    1119779-2021-00700
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 1, 2021
    Report Date
    September 4, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER REPORTED FALSE POSITIVE RESULTS ON A BD BACTEC FX TOP INSTRUMENT (P/N 441385, S/N (B)(6)) ON MULTIPLE STATIONS OF DRAWER D. NO ERRONEOUS RESULTS WERE REPORTED TO DOCTORS, AND PATIENTS WERE NOT IMPACTED. CUSTOMER VERIFIED AND NOTICED THAT THE GROWTH CURVES WERE LOOK ABNORMAL. TEMPERATURE OF THE DRAWER WAS WITHIN SPECIFICATIONS AND NO TECHNICAL ERROR MESSAGES WERE VISIBLE. A BD FILED SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND THAT 2 POTENTIAL ISSUES. 5V READING WAS 5.48V ADJUSTED THIS TO 5.08V (SPECIFICATION WAS 5.05V TO 5.10V AND THERE WAS A FAN BLOWING AT THE RIGHT SIDE OF THE INSTRUMENT. THE METAL ON THE LEFT AND RIGHT SIDE WERE DIFFERENT IN TEMPERATURE, WHEN DRAWER WAS OPENED FOR A MINUTE, THE TEMPERATURE DROPPED WITH 1 DEGREE CELSIUS AND ADJUSTED THE FAN, SO IT DID NOT BLOW DIRECTLY TOWARDS THE INSTRUMENT. THE RECOMMENDED SOLUTION WAS TO MOVE BACTEC FX 3 NEXT TO BACTEC FX 2 WHICH CREATED A MORE STABLE ENVIRONMENT AROUND BACTEC FX 3. REVIEW OF THE DEVICE HISTORY RECORD IS NOT REQUIRED DUE TO THE AGE OF THE INSTRUMENT. SERVICE HISTORY RECORD REVIEW REVEALED NO PREVIOUS COMPLAINTS FOR FALSE POSITIVE RESULTS. BD QUALITY DID NOT RECEIVE ANY RETURNED INSTRUMENT OR PARTS FOR INVESTIGATION. THIS COMPLAINT IS A CONFIRMED FAILURE OF A BD PRODUCT. THE ROOT CAUSE IS VOLTAGE ISSUE AND INSTRUMENT ENVIRONMENT. NO NEW TRENDS, RISKS, OR HAZARDS WERE IDENTIFIED AS A RESULT OF THE COMPLAINT. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH THIS FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD BACTEC¿ FX, INSTRUMENT TOP, PACKAGED FALSE POSITIVE RESULTS WERE OBTAINED IN DRAWER D. THERE WAS NO REPORT OF CONFIRMATORY TEST OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULTS ON MULTIPLE STATIONS OF DRAWER D CUSTOMER VERIFIED AND NOTICED THAT THE GROWTH CURVES LOOK ABNORMAL. TEMPERATURE OF THE DRAWER IS WITHIN SPECS, AND NOT TECHNICAL ERROR MESSAGES ARE VISIBLE.

    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 FALSE POSITIVE RESULTS WERE OBTAINED IN DRAWER D. THERE WAS NO REPORT OF CONFIRMATORY TEST OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FALSE POSITIVE RESULTS ON MULTIPLE STATIONS OF DRAWER D CUSTOMER VERIFIED AND NOTICED THAT THE GROWTH CURVES LOOK ABNORMAL. TEMPERATURE OF THE DRAWER IS WITHIN SPECS, AND NOT TECHNICAL ERROR MESSAGES ARE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602746 BD BACTEC FX, INSTRUMENT TOP, PACKAGED SYSTEM, BLOOD CULTURING MDB BECTON, DICKINSON & CO. (SPARKS) 441385 NA 00382904413859

    Patients

    Seq Age Sex Outcome Treatment
    1