BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1811789 · Received August 23, 2010

    Report

    Report Number
    2122870-2010-00464
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 23, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC AND SYSTEM CHECK DATA ARE NOT AVAILABLE. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED MAJOR PREVENTIVE MAINTENANCE AND REPLACED HARDWARE. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS SEVERAL ERRONEOUSLY LOW INSULIN RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. ONLY ONE DATA WAS PROVIDED BY THE CUSTOMER. PATIENT TREATMENT WAS MOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1