BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1810529 · Received August 20, 2010

    Report

    Report Number
    2122870-2010-00462
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC HAS BEEN WITHIN THE CUSTOMER'S ESTABLISHED RANGE. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE AND PERFORMED A SYSTEM CHECK WHICH PASSED AND A PRECISION TEST AND NOTED NO HARDWARE ISSUES. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED TROPONIN (ACCU TNI) RESULT OF 0.58NG/ML GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT TESTING PRODUCED A RESULT OF 0.04NG/ML WITHIN 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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1