BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1923496 · Received December 13, 2010

    Report

    Report Number
    2122870-2010-00882
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 14, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM CHECK WAS PERFORMED AFTER THE ERRONEOUS RESULT AND THE UNWASHED PORTION FAILED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010. THE FSE PERFORMED A PREVENTATIVE MAINTENANCE (PM) AND REBUILT THE PRECISION PUMP. THE FSE THEN PERFORMED A SYSTEM CHECK AND SPECIFICATIONS WERE MET. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO CLEAR ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING LOW TROPONIN (ACCUTNI) RESULT WITHIN THE RISK STRATIFICATION RANGE FOR ONE PATIENT'S SAMPLE. UPON REPEAT THE RESULTS WERE ABOVE THE AMI CUTOFF. THE NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1