BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1802047 · Received August 16, 2010

    Report

    Report Number
    2122870-2010-00432
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A PST TUBE. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES PRIOR TO THE EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A DIAGNOSTIC TESTING WHICH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING TROPONIN (ACCU TNI) RESULTS IN THE RISK STRATIFICATION RANGE AND ABOVE THE AMI CUT-OFF GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON THIS INSTRUMENT AND ON AN ALTERNATE METHOD RESULTED IN THE NORMAL REFERENCE RANGE. THE RESULTS WERE REPORTED OUT OF THE LAB. 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

    Patients

    Seq Age Sex Outcome Treatment
    1