BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2003445 · Received March 1, 2011

    Report

    Report Number
    2122870-2011-00507
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN CUSTOMER'S SPECIFICATIONS PRIOR TO THE EVENT. A BCI FIELD SERVICE ENGINEER (FSE) NOTED THAT ALL PREVIOUS SYSTEM CHECKS FOR THIS INSTRUMENT PASSED WITHIN INSTRUMENT SPECIFICATIONS FSE PERFORMED: REQUIRED HARDWARE VERIFICATION TESTING; NO ISSUES WERE NOTED. A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. REPLACED THE MIXER A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT WITH THE DATA PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO RECEIVING ACCUTNI RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY; HENCE NO IMPACT TO PATIENT TREATMENT. THE SAMPLES WERE REPEATED ON THE SAME UNIT AND LOWER RESULT WITHIN THE NORMAL REFERENCE RANGE 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