BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 14048064 · Received April 7, 2022

    Report

    Report Number
    1119779-2022-00523
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Date of Event
    March 14, 2022
    Report Date
    July 11, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    OOI
    UDI-DI
    00382904419165
    PMA / PMN Number
    K111860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: (B)(4). 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 441916AND SERIAL NUMBER (B)(6)) HAD A "FALSE POSITIVE¿. CUSTOMER REPORTED THAT THEY HAVE BEEN RECEIVING FALSE POSITIVE ON COV-2 ASSAY. UPON RERUNNING OF THE SAMPLES, THE RESULTS WERE NEGATIVE. CUSTOMER PERFORMED EM AND FOUND IT ON THE ZONE ASSOCIATED WITH KEYBOARD AND MOUSE. CUSTOMER PERFORMED NEGATIVE QC ON A NEW LOT AND HAD NO ISSUE. CUSTOMER PERFORMED DEEP CLEANING WITH INSTRUCTION PROVIDED BY SERVICE. FOLLOW-UP EM WAS PERFORMED WITH NEGATIVE RESULTS. CUSTOMER PERFORMED RUNS WITH PATIENT SAMPLES, ALL WERE REPORTED NEGATIVE. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT SERIAL NUMBER, (B)(4) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR A FAILURE AT INSTALL. DEVICE WAS INSTALLED ON (B)(6)2020, 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 WAS NOT PERFORMED. ROOT CAUSE IS DETERMINED TO BE DUE TO CONTAMINATION ON THE MOUSE AND KEYBOARD. COMPLAINT IS UNCONFIRMED AS THE CAUSE NOT INSTRUMENT RELATED AND DUE TO WORKFLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS WERE OBTAINED. PATIENT 9 OF 12. CONFIRMATORY TESTING WAS PERFORMED USING A CEPHEID ANALYZER. 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: RUN 953 POSITION A12 ACCESSION (B)(4) (POSITIVE) - REPEATED NEGATIVE ON CEPHEID ANALYZER. IT WAS REPORTED THAT THERE ARE SEVERAL DISCREPANT RESULTS CUSTOMER HAS OBSERVED AN INCREASE IN COV2 POS RESULTS. DISCREPANT RESULTS HAVE AFFECTED PATIENT RESULTS, MORE SO. INITIALLY THE KEYBOARD AREA SHOWED SOME CONTAMINATION BUT WHEN REPEATED, THE RESULT WAS NEG. CUSTOMER EVEN RAN SOME BLANK SBT TUBES - SOME WERE POS AT FIRST, THEN NEG ON REPEAT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING WITH BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT FALSE POSITIVE RESULTS WERE OBTAINED. PATIENT 9 OF 12. CONFIRMATORY TESTING WAS PERFORMED USING A CEPHEID ANALYZER. 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: RUN 953 POSITION A12 ACCESSION 822086 (POSITIVE) - REPEATED NEGATIVE ON CEPHEID ANALYZER IT WAS REPORTED THAT THERE ARE SEVERAL DISCREPANT RESULTS CUSTOMER HAS OBSERVED AN INCREASE IN COV2 POS RESULTS. DISCREPANT RESULTS HAVE AFFECTED PATIENT RESULTS, MORE SO. INITIALLY THE KEYBOARD AREA SHOWED SOME CONTAMINATION BUT WHEN REPEATED, THE RESULT WAS NEG. CUSTOMER EVEN RAN SOME BLANK SBT TUBES - SOME WERE POS AT FIRST, THEN NEG ON REPEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810552 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