BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 1823131 · Received September 1, 2010

    Report

    Report Number
    2122870-2010-00500
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 5, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LGD
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES ARE SERUM. CENTRIFUGATION INFORMATION WAS NOT SUPPLIED. QC PRIOR TO AND AFTER THE EVENT WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. CUSTOMER PRODUCT LINE SUPPORT (CPLS) TESTED THE PATIENT SAMPLES BUT COULD NOT REPRODUCE THE CUSTOMER'S RESULTS. THE RESULTS WERE NON-REACTIVE ON TOXO IGG ASSAY. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. CPLS TESTED THE SAMPLES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUSLY REACTIVE TOXO IGG RESULTS ON TWO PATIENT SAMPLES GENERATED BY ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE REPEAT TESTS ON THE SAME INSTRUMENT AND AN ALTERNATE METHOD RESULTED AS NON-REACTIVE. 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 LGD BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1