BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 13196618 · Received January 7, 2022

    Report

    Report Number
    3007420875-2021-00068
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 14, 2021
    Report Date
    April 21, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904438128
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED: SITE LEGAL NAME (FDA): BECTON, DICKINSON & CO. - SPARKS, MD / 21152 B5. IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: KIT BD MAX EXT ENTERIC BACTERIAL PANEL THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: THE RESULT IS RETURNED POSITIVE FOR PLESIOMONAS AND / OR VIBRIO. BUT WE SEE THAT THE CURVE CORRESPONDS MORE TO BACKGROUND NOISE: WEAK FLUORESCENCE, IRREGULAR CURVE, AND HIGH CT VALUES. THE PREVALENCE OF VIBRIO AND PLESIOMONAS IS NORMALLY LOW AND HAVING SEVERAL POSITIVES IN THE SAME SERIES IS DOUBTFUL. D1. MEDICAL DEVICE BRAND NAME: BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT D2A. COMMON DEVICE NAME: INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS D2B. MEDICAL DEVICE TYPE: OOI D3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (SPARKS) D4: CATALOG #: 441916 EXPIRATION DATE: NA LOT #: NA SERIAL #: (B)(6) UDI #: (B)(4) G1. MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (SPARKS) G5. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED: K111860, K130470 H4. DEVICE MANUFACTURE DATE: 2017-03-06 H5. LABELED FOR SINGLE USE?: NO

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    INVESTIGATION SUMMARY: THE COMPLAINT ALLEGES THE BD MAX INSTRUMENT CATALOG NUMBER 441916 AND SERIAL NUMBER (B)(6) HAD A "FALSE POSITIVE". CUSTOMER REPORTED THAT THEY ARE RECEIVING FALSE POSITIVE FOR VIBRIO AND PLESIO ON XEBP ASSAY. FIELD SERVICE WAS DISPATCHED. FIELD SERVICE RENORMALIZED BOTH READER. 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) 2017, 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. RETURNED SAMPLE ANALYSIS CONSIST OF REVIEW OF DATABASE AND RUN FILES PROVIDED BY THE CUSTOMER. REVIEW OF THE RUN FILES SHOWS POSITIVE RESULTS FOR VIBRIO ON LANE B2, B4, AND B12 AND POSITIVE RESULTS FOR PLESIO ON LANE B2, B3, B11, AND B12. REVIEW OF THE DATABASE SHOWS THAT THE RAW PCR SIGNAL WAS SHAKY EVEN WHEN ZOOMED OUT BUT RELATIVELY FLAT ON ROX AND CY5 IN THOSE LANES. BACKGROUND CORRECT PCR SHOW POSITIVE AMPLIFICATION ON THOSE ASSOCIATED LANES CONFIRMING THE FALSE POSITIVE. REVIEW OF THE NORMALIZATION DATA SHOWS THAT B-SIDE ROX AND CY5 HAD DRIFT WHICH LEAD TO THE AMPLIFICATION OF THE PCR CURVE CAUSING THE FALSE POSITIVE. ROOT CAUSE IS DUE TO NORMALIZER DRIFT. COMPLAINT IS CONFIRMED BY QUALITY REVIEW OF THE DATABASE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: KIT BD MAX EXT ENTERIC BACTERIAL PANEL THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: THE RESULT IS RETURNED POSITIVE FOR PLESIOMONAS AND / OR VIBRIO. BUT WE SEE THAT THE CURVE CORRESPONDS MORE TO BACKGROUND NOISE: WEAK FLUORESCENCE, IRREGULAR CURVE, AND HIGH CT VALUES. THE PREVALENCE OF VIBRIO AND PLESIOMONAS IS NORMALLY LOW AND HAVING SEVERAL POSITIVES IN THE SAME SERIES IS DOUBTFUL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USE WITH THE KIT BD MAX EXT ENTERIC BACTERIAL PANEL, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: THE RESULT IS RETURNED POSITIVE FOR PLESIOMONAS AND / OR VIBRIO. BUT WE SEE THAT THE CURVE CORRESPONDS MORE TO BACKGROUND NOISE: WEAK FLUORESCENCE, IRREGULAR CURVE, AND HIGH CT VALUES. THE PREVALENCE OF VIBRIO AND PLESIOMONAS IS NORMALLY LOW AND HAVING SEVERAL POSITIVES IN THE SAME SERIES IS DOUBTFUL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE TESTING WITH THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT, FALSE POSITIVE RESULTS WERE OBTAINED. THERE WAS NO INDICATION THAT ERRONEOUS RESULTS WERE REPORTED OUT, AND THERE WAS NO REPORT OF PATIENT IMPACT. ASSAYS USED: KIT BD MAX EXT ENTERIC BACTERIAL PANEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: THE RESULT IS RETURNED POSITIVE FOR PLESIOMONAS AND / OR VIBRIO. BUT WE SEE THAT THE CURVE CORRESPONDS MORE TO BACKGROUND NOISE: WEAK FLUORESCENCE, IRREGULAR CURVE, AND HIGH CT VALUES. THE PREVALENCE OF VIBRIO AND PLESIOMONAS IS NORMALLY LOW AND HAVING SEVERAL POSITIVES IN THE SAME SERIES IS DOUBTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682464 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 443812 1202512 00382904438128
    993286 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 443812 1202512 00382904438128

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown