BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1903886 · Received November 20, 2010

    Report

    Report Number
    2122870-2010-00761
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 19, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES ARE COLLECTED IN LITHIUM HEPARIN GEL TUBES AND RUN WITH INSERT CUPS WITH THE SAMPLES ALIQUOTED FROM THE PRIMARY TUBE. THE LABORATORY HAS AN ACCUTNI PATIENT SAMPLE PROCEDURE WHERE ALL RESULTS OF >0.05NG/ML ARE REPEATED. THERE WERE NO QC ISSUES PRIOR TO THIS EVENT. A SYSTEM CHECK RUN ON (B)(6) 2010 WAS WITHIN SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A PREVENTIVE MAINTENANCE (PM) AND REPLACED INCUBATOR BELT. THE FSE RAN A SYSTEM CHECK AND ALL PARAMETERS PASSED WITHIN SPECIFICATIONS. THE FSE RAN A DIAGNOSTIC TEST AND QC; ALL RESULTS PASSED WITHIN ACCEPTABLE LIMITS. ALTHOUGH HARDWARE ISSUES WERE ADDRESSED, NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING ERRONEOUS TROPONIN (ACCUTNI) RESULTS, WITHIN THE RISK STRATIFICATION RANGE, GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR TWO PATIENTS' SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. UPON REPEAT ON THIS AND ON A DIFFERENT INSTRUMENT THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT REPORT EFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO 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 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1