BEUDAMED
    FDA Adverse Event Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1911180 · Received November 30, 2010

    Report

    Report Number
    2122870-2010-00821
    Date Received
    November 30, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION IS UNAVAILABLE. PER CUSTOMER, QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. ONE SAMPLE WAS SUBMITTED TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) FOR ADDITIONAL TESTING. CPLS TESTING CONFIRMED THE ROOT CAUSE OF THE EVENT TO BE A HETEROPHILE INTERFERENCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO THREE ERRONEOUS ELEVATED ACCUTNI RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND "NEGATIVE" RESULT WAS OBTAINED. THE PATIENT WAS TRANSPORTED TO ANOTHER HOSPITAL, WHERE A TROPONIN T TEST WAS PERFORMED USING AN ALTERNATE METHOD AND NEGATIVE RESULT WAS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization