BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT

    MDR report key: 14137839 · Received April 18, 2022

    Report

    Report Number
    1119779-2022-00571
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    June 21, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510(K) NUMBERS. PMA/510(K)#: K111860. 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 441916 AND SERIAL NUMBER (B)(6)) HAD "EPP FPS & UNRS / CDIFF INDS". THE COMPLAINT IS UNABLE TO BE CONFIRMED WITH THE INFORMATION PRESENT. THE ROOT CAUSE IS "UNKNOWN". IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED. REVIEW OF DEVICE HISTORY RECORD FOR INSTRUMENT (B)(6) IS NOT REQUIRED BECAUSE THIS COMPLAINT DOES NOT ALLEGE AN EARLY LIFE FAILURE OR FAILURE AT INSTALLATION AND HAS CHANGED CONFIGURATION SINCE RELEASE FROM MANUFACTURING DUE TO SERVICE REPAIRS/PMS. DEVICE WAS INSTALLED ON 1/21/2019. SAMPLES WERE NOT RECEIVED BY QUALITY FOR INVESTIGATION AND THUS, RETURNED MATERIAL INVESTIGATION COULD NOT OCCUR. REVIEW OF SERVICE HISTORY FOR THIS DEVICE DID NOT REVEAL ANY PRIOR EVENTS RELATED TO THIS FAILURE MODE. BD QUALITY WILL CONTINUE TO MONITOR TRENDS ASSOCIATED WITH THIS FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL, THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT PRODUCED 11 FALSE POSITIVE RESULTS. CONFIRMATORY TESTING WAS DONE VIA MICROSCOPY. NO RESULTS WERE REPORTED AND NO REPORTED IMPACT ON PATIENT CARE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT EPP UNRS AND CDIFF IND RESULTS. CUSTOMER STATED THEY HAD 13 POSITIVE RESULTS ON EPP, BUT CONFIRMED AT LEAST 11 OF THESE TO BE NEGATIVE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD MAX¿ ENTERIC PARASITE PANEL, THE BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT PRODUCED 11 FALSE POSITIVE RESULTS. CONFIRMATORY TESTING WAS DONE VIA MICROSCOPY. NO RESULTS WERE REPORTED AND NO REPORTED IMPACT ON PATIENT CARE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED BY THE CUSTOMER THAT EPP UNRS AND CDIFF IND RESULTS. CUSTOMER STATED THEY HAD 13 POSITIVE RESULTS ON EPP, BUT CONFIRMED AT LEAST 11 OF THESE TO BE NEGATIVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627360 BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT INSTRUMENTATION FOR CLINICAL MULTIPLEX TEST SYSTEMS OOI BECTON, DICKINSON & CO. (SPARKS) 441916 N/A 00382904419165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown