BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2193441 · Received May 11, 2011

    Report

    Report Number
    2122870-2011-01377
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    September 5, 2008
    Report Date
    September 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SVC ENGINEER (FSE) PERFORMED CARRYOVER TESTING ON (B)(4) 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 SYS CHECK AND PRECISION TESTING PRIOR AND AFTER THE INCIDENT DATE AND THEY MET THE SPEC. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FROM THIS EVENT. THIS IS FIVE OF FIVE REPORTS RELATED TO FIVE PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT OCCURRING ON DIFFERENT DAYS. SEE MDR 2122870-2011-01323, 01325, 01375, 01376, AND 01377 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN) RESULTS ON 5 DIFFERENT PTS OCCURRING ON DIFFERENT DAYS. RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYS. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT AND THEY WERE WITHIN THE SPECIFIC RANGE. THE INITIAL, ELEVATED ACCUTNI RESULTS WERE REPORTED OUTSIDE THE LAB. THERE ARE NOT REPORTS OF ANY ADVERSE PT CONSEQUENCE OR CHANGE TO THE PTS' TREATMENT. THERE ARE NOT INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT. THIS REPORT REFERS TO PT NUMBER FIVE.

    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 ACCESS ACCUTNI