BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2242326 · Received September 10, 2011

    Report

    Report Number
    2122870-2011-03412
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A 7 ML PST TUBE AND CENTRIFUGED AT ROOM TEMPERATURE FOR 3 MINUTES. PER CUSTOMER SUPPLIED DATA, A SYSTEM CHECK ON (B)(6) 2011, ACCUTNI CALIBRATION ON (B)(6) 2010 PASSED WITHIN SPECIFICATIONS. A SYSTEM CHECK PERFORMED ON (B)(6) 2011 FAILED THE WASHED PORTION. THE CUSTOMER RAN A DAILY CLEAN AND RERAN A SYSTEM CHECK ON (B)(6) 2011 WHICH PASSED. QUALITY CONTROL RESULTS FOR THREE LEVELS OF ACCUTNI WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON (B)(6) 2011. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THE EVENT ON (B)(6) 2011. THE FSE REPLACED THE PIPETTOR, DISPENSE PROBES, INCUBATOR BELT, AND INCUBATOR CLIPS. THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH FAILED. THE FSE REPLACED INCUBATOR BELT BEARINGS AND WASH CAROUSEL BEARINGS AND RERAN THE HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED. A ROOT CAUSE WAS NOT DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING A TROPONIN (ACCUTNI) RESULT ABOVE THE AMI CUT-OFF FOR ONE (1) EMERGENCY ROOM (ER) PATIENT. THE RESULT WAS GENERATED BY AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS ACCUTNI CALIBRATORS (LOT 018864) AND ACCUTNI REAGENT (LOT 112157). THE RESULT WAS REPORTED OUT OF THE LABORATORY. EARLIER ON THE DAY OF THE EVENT, A PREVIOUS SAMPLE FROM THE SAME PATIENT YIELDED A RESULT WITHIN THE NORMAL REFERENCE RANGE. SUBSEQUENT TESTING ON THE SAME INSTRUMENT YIELDED RESULTS WITHIN THE NORMAL REFERENCE RANGE. THERE WERE NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT MADE IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR