BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2193289 · Received May 11, 2011

    Report

    Report Number
    2122870-2011-01323
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    September 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) PERFORMED CARRYOVER TESTING ON (B)(6) 2008 AND (B)(6) 2008 AND IT FAILED. FSE REPLACED THE TRANSDUCER, SUBSTRATE PROBE, WASH TOWER VALVE, ASPIRATE PROBES, AND ALL MIXER SPINNERS. FSE ALSO CLEANED THE ANALYTICAL MODULE. THE FSE PERFORMED SYSTEM CHECK AND PRECISION TESTING PRIOR AND AFTER THE INCIDENT DATE THEY MET THE SPECIFICATION. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FROM THIS EVENT. THIS IS ONE OF FIVE REPORTS RELATED TO FIVE PATIENT EVENT ASSOCIATED WITH A SINGLE MALFUNCTION REPORT OCCURRING ON DIFFERENT DAYS. SEE MDR 2122870-2011-01325, MDR 2122870-2011-01375, MDR 2122870-2011-01376, AND MDR 2122870-2011-01377 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS ON 5 DIFFERENT PATIENTS OCCURRING ON DIFFERENT DAYS. RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THEY WERE WITHIN THE SPECIFIC RANGE. THE INITIAL, ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. A PATIENT WAS HELD FOR OBSERVATIONS ONLY. THE DETAILS OF WHICH PATIENT WAS HELD FOR OBSERVATION IS UNKNOWN. THIS REPORT REFERS TO PATIENT NUMBER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization ACCESS ACCUTNI