BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 12751917 · Received November 4, 2021

    Report

    Report Number
    1119779-2021-01762
    Event Type
    Malfunction
    Date Received
    November 4, 2021
    Date of Event
    October 6, 2021
    Report Date
    March 9, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    K130470
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6)) HAD A "FALSE POSITIVE" RESULT. CUSTOMER REPORTED THAT THEY ARE RECEIVING FALSE POSITIVE RESULTS ON VIBRIO. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE DISASSEMBLED AND CLEANED THE READERS, NORMALIZED BOTH READERS, AND CLEANED THE INSIDE OF THE INSTRUMENT. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR A FAILURE AT INSTALL. DEVICE WAS INSTALLED ON 16NOV2018, AND SINCE THEN OTHER SERVICE ACTIVITIES HAVE OCCURRED, SUCH AS PREVENTATIVE MAINTENANCE AND REPAIR, WHICH HAVE CHANGED THE CONFIGURATION OF THE INSTRUMENT SINCE RELEASE FROM MANUFACTURING. SERVICE HISTORY REVIEW WAS PERFORMED FOR THE INSTRUMENT (B)(6) AND NO ADDITIONAL WORK ORDER WAS OBSERVED FOR THE COMPLAINT FAILURE MODE REPORTED. NO SAMPLES WERE RETURNED FOR INVESTIGATION, THEREFORE RETURNED SAMPLE ANALYSIS IS NOT PERFORMED. ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE COMPLAINT IS CONFIRMED BY APPLICATION SPECIALIST DURING VISIT AND BY FIELD SERVICE DURING DISPATCH. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME TUBES PRODUCED FALSE NEGATIVE CURVES ON THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, DESPITE RETURNING POSITIVE VIBRIO RESULTS WITH APPROPRIATE CT VALUES. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE CLIENT QUESTIONS THE RESULTS OBTAINED ON THE RUN THIS MORNING ON A RUN OF 11 TUBES - 8 RETURNED A VIBRIO POS RESULT WITH SUITABLE CT VALUES BUT A NEGATIVE CURVE."

    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 THAT SOME TUBES PRODUCED FALSE NEGATIVE CURVES ON THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, DESPITE RETURNING POSITIVE VIBRIO RESULTS WITH APPROPRIATE CT VALUES. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CLIENT QUESTIONS THE RESULTS OBTAINED ON THE RUN THIS MORNING ON A RUN OF 11 TUBES: 8 RETURNED A VIBRIO POS RESULT WITH SUITABLE CT VALUES BUT A NEGATIVE CURVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649080 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 441916 NA 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown