BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 1914337 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00847
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES. ON (B)(6) 2010 THE CUSTOMER PERFORMED SYSTEM CHECK, WHICH MET SPECIFICATIONS. THE CUSTOMER PERFORMED A DIAGNOSTIC SYSTEM CHECK, WHICH FAILED THE WASH PORTION. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED A PREVENTIVE MAINTENANCE. FSE RAN SYSTEM CHECK AND QC; BOTH WERE WITHIN SPECIFICATIONS. FSE DID NOT NOTE ANY HARDWARE ISSUES WITH THE UNIT. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO AN ERRONEOUS ELEVATED ACCUTNL RESULT ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF FOR ONE PATIENT GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY. THE ERRONEOUS SAMPLE WAS RETESTED ON THE SAME UNIT AND LOWER RESULT WAS OBTAINED. 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 MMI BECKMAN COULTER INC. ACCESS 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1