BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿

    MDR report key: 12328265 · Received August 16, 2021

    Report

    Report Number
    3007420875-2021-00042
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 29, 2021
    Report Date
    January 20, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904439859
    PMA / PMN Number
    K181427
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE COMPLAINT OF "FALSE POSITIVE" WAS REPORTED AGAINST THE BD MAX INSTRUMENT CATALOG NUMBER 441916, SERIAL NUMBER (B)(6). CUSTOMER REPORTED RECEIVING FALSE POSITIVE RESULTS ON EVP NOV. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE REPLACED THE STEPPER MOTOR ON READER B, NORMALIZED READER A, AND CLEAN BOTH READER. INSTRUMENT WAS RETURNED TO CUSTOMER FUNCTIONAL. NO PARTS WERE RETURNED TO BD FOR INVESTIGATION. COMPLAINT WAS CONFIRMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. INVESTIGATION CONSISTED OF A REVIEW OF THE INSTRUMENT INSTALLATION, SERVICE HISTORY, AND RELATED COMPLAINT DATA. NO NEW RISKS, TRENDS, OR HAZARDS WERE IDENTIFIED. BD WILL CONTINUALLY MONITOR FOR TREND.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.5. EVENT DESCRIPTION: IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "SINCE NEW KIT HAVE FOUND PROBABLY FALSE POSITIVES." D.1. DEVICE BRAND NAME: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT. D.2. PRODUCT CODE: OOI; COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS. D.3. DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (SPARKS). D.4. DEVICE CATALOG NUMBER: 441916; DEVICE SERIAL NUMBER: (B)(6) .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "SINCE NEW KIT HAVE FOUND PROBABLY FALSE POSITIVES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT ¿FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SINCE NEW KIT HAVE FOUND PROBABLY FALSE POSITIVES."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING KIT BD MAX ENTERIC VIRAL PANEL FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "SINCE NEW KIT HAVE FOUND PROBABLY FALSE POSITIVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220801 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 443985 1074267 00382904439859
    1220807 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 443985 1074267 00382904439859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown