BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2001941 · Received February 27, 2011

    Report

    Report Number
    2122870-2011-00465
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    March 5, 2010
    Report Date
    January 27, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO AND AFTER THE EVENT. SERVICE WAS NOT REQUESTED AS THIS EVENT WAS ISOLATED TO ONE PATIENT'S SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING PTH RESULTS ABOVE THE ASSAY LINEARITY FOR ONE PATIENT SAMPLE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM THAT DID NOT MATCH THE CLINICAL PICTURE. THE PATIENT'S LAST PTH THAT RESULTED BELOW THE ASSAY LINEARITY WAS 348PG/ML ON (B)(6) 2009. 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 JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1