BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 14518051 · Received May 26, 2022

    Report

    Report Number
    1119779-2022-00767
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 2, 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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510(K) NUMBERS. PMA/510(K)#: K111860. INITIAL REPORTER ADDRESS: (B)(6). 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

    H6: INVESTIGATION SUMMARY: 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 FOR EPP. DATABASE AND RUNFILE WAS PROVIDED. REVIEW OF THE DATABASE AND LOG FILE SHOWS THAT THERE IS A BUBBLE CAUSING THE DISCREPANT RESULTS. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE MOVED THE INSTRUMENT AND PERFORMED PM AND QUALIFICATION. DURING QUALIFICATION, FIELD SERVICE NOTED THAT THERE IS AIR IN THE TIPS. FIELD SERVICE REPLACED PUMP #2. INSTRUMENT WAS RETURNED TO THE CUSTOMER. 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 (B)(6)2018, 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. SAMPLE ANALYSIS CONSISTED OF REVIEW OF DATABASE AND RUN FILES. REVIEW OF RUN 391 FOR (B)(6), A6 HAD A POSITIVE RESULT FOR CRYPTO. ANALYSIS OF THE PCR CURVE FOR RAW ROX CHANNEL SHOWS A SUDDEN DROP AND INCREASE IN THE CURVE. OTHER OPTIC CHANNELS WERE ANALYZED AND FAM AND VIC BOTH EXHIBIT THE SAME BEHAVIOR. THIS IS INDICATIVE THAT THERE IS BUBBLE IN THE CARTRIDGE FOR THAT PARTICULAR LANE. REVIEW OF RUN 390, LANE A2 DID NOT EXHIBIT ANY FALSE POSITIVE, BUT THE CURVES SHOWS THE SAME BEHAVIOR AS THE CURVES ON LANE A6 OF RUN 391, WHICH INDICATES THAT PUMP #2 IS FAILING. ROOT CAUSE IS DETERMINED TO BE DUE TO THE LOW PERFORMANCE OF THE PUMP BY ANALYSIS OF THE CURVES AND IS FURTHER REINFORCE BY OBSERVATION MADE BY FIELD SERVICE. COMPLAINT IS CONFIRMED BY QUALITY REVIEW OF THE DATABASE AND RUN FILES. REVIEW OF RISK MANAGEMENT FILES CONFIRMS THERE ARE NO NEW, MODIFIED, OR ADDITIONAL RISKS ASSOCIATED WITH THIS FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT A FALSE POSITIVE RESULT WAS PRODUCED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "FALSE CAMPY POSITIVE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT A FALSE POSITIVE RESULT WAS PRODUCED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "FALSE CAMPY POSITIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851837 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