BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1930591 · Received December 16, 2010

    Report

    Report Number
    2122870-2010-00921
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO VISIBLE FIBRIN IN THE PATIENT'S SAMPLE. PER CUSTOMER, QC AND SYSTEM CHECKS WERE WITHIN SPECIFICATIONS DURING THIS EVENT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK, BUT RESULTS WERE NOT SUPPLIED. THE FSE INSPECTED THE INSTRUMENT AND FOUND NO HARDWARE ISSUES THAT WOULD HAVE CONTRIBUTED TO AN ERRONEOUS RESULT. NO CLEAR ROOT CAUSE COULD BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING OBTAINING A TROPONIN (ACCUTNI) RESULT IN THE RISK STRATIFICATION RANGE THAT REPEATED ABOVE THE AMI CUTOFF ON ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. CUSTOMER DOES NOT RECALL WHICH RESULT WAS REPORTED OR WHICH RESULT IS BELIEVED TO BE TRUE. HOWEVER, THEY STATED NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE 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 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1