BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1920267 · Received December 10, 2010

    Report

    Report Number
    2122870-2010-00878
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN SST TUBES AND CENTRIFUGED FOR 8 MINUTES AT 3000RPM. PER THE CUSTOMER, QC WAS WITHIN THE ESTABLISHED RANGES PRIOR TO THE ERRONEOUS RESULTS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010. FSE CLEANED AND INSPECTED THE INSTRUMENT. THE FSE PERFORMED A HARDWARE PROTOCOL ON THE INSTRUMENT AND ALL VERIFICATION MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. A CLEAR ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ELEVATED ACCUTNI (TROPONIN) RESULTS WITHIN THE RISK STRATIFICATION RANGE FOR TWO PATIENTS' SAMPLES THAT WERE GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. UPON REPEAT THE RESULTS WERE IN THE NORMAL REFERENCE RANGE. 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