BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 1823132 · Received September 1, 2010

    Report

    Report Number
    2122870-2010-00504
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 1, 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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS SERUM. SAMPLE CLOTTING TIME AND CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC DURING THE EVENT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. SERVICE WAS ON SITE ON (B)(4) 2010 AND PERFORMED A PREVENTIVE MAINTENANCE (PM). A SYSTEM CHECK WAS PERFORMED AND MET SPECIFICATIONS. NO HARDWARE ISSUE WAS NOTED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUSLY LOW TROPONIN (ACCUTNI) RESULT ON ONE PATIENT GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS REPORTED OUT OF THE LABORATORY. UPON REPEAT, THE RESULTS WERE WITHIN THE RISK STRATIFICATION RANGE AND BETTER FIT THE PATIENT'S CLINICAL PICTURE. NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAS BEEN REPORTED 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 MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1