BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 14465143 · Received May 21, 2022

    Report

    Report Number
    1119779-2022-00744
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    November 10, 2021
    Report Date
    August 18, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. ADDITIONAL PHONE NUMBERS: (B)(6). MULTIPLE 510K NUMBERS WERE REPORTED TO BE INVOLVED: K111860, K130470 A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT (CATALOG NUMBER 441916AND SERIAL NUMBER (B)(6)) HAD A "FALSE POSITIVE¿. CUSTOMER REPORTED THAT THEY HAD FALSE POSITIVE RESULTS ON EPP. BD MANUFACTURING ENGINEER AND SYSTEM ENGINEER VISITED THE SITE AND INVESTIGATED THE INSTRUMENT. THEY NOTED THAT WERE FILAMENTS IN THE CARTRIDGE AND THAT THERE WERE SEVERAL ALIGNMENT CORRECTION THAT HAD TO BE DONE. INTERNAL TEAM RECOMMENDED INSTALLING THE FIXED MAGNET ASSEMBLY. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE INSTALLED THE FIXED MAGNET ASSEMBLY TO THE INSTRUMENT. CUSTOMER PLAN TO REFRAIN FROM PERFORMING INTERLEAVE RUNS TO MINIMIZE POTENTIAL ISSUES. 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 21 JAN 2019, 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 IN AUGUST 2021, THE INSTRUMENT EXPERIENCE DISCREPANT ISSUES WITH EPP. NO SAMPLES WERE RETURNED FOR INVESTIGATION, THEREFORE RETURNED SAMPLE ANALYSIS WAS NOT PERFORMED. ROOT CAUSE CANNOT BE DETERMINED TO BE DUE TO CONTAMINATION INSIDE THE INSTRUMENT. COMPLAINT IS CONFIRMED BY SERVICE. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR TRENDS ASSOCIATED WITH THIS FAILURE MODE.

    Additional Manufacturer Narrative · 0

    AFTER ADDITIONAL REVIEW, THIS MFR# 1119779-2022-00744 SHOULD BE CONSIDERED CANCELED. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MFR # 1119779-2022-00571.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THE CUSTOMER MAY HAVE RECEIVED FALSE POSITIVE RESULTS. AT THIS TIME IT IS UNCLEAR WHETHER OR NOT PATIENT SAMPLES WERE INVOLVED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EPP ASSAY RESULTS INVESTIGATION"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THE CUSTOMER MAY HAVE RECEIVED FALSE POSITIVE RESULTS. AT THIS TIME IT IS UNCLEAR WHETHER OR NOT PATIENT SAMPLES WERE INVOLVED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EPP ASSAY RESULTS INVESTIGATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT THE CUSTOMER MAY HAVE RECEIVED FALSE POSITIVE RESULTS. AT THIS TIME IT IS UNCLEAR WHETHER OR NOT PATIENT SAMPLES WERE INVOLVED. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EPP ASSAY RESULTS INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526594 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 441916 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown