BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1831558 · Received September 10, 2010

    Report

    Report Number
    2122870-2010-00533
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 13, 2010
    Report Date
    September 10, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REAGENT PACK ISSUES MAY BE A CONTRIBUTING FACTOR, NO CLEAR ROOT CAUSE COULD BE DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A TROPONIN (ACCUTNI) RESULT OF 0.00NG/ML FOR ONE PATIENT SAMPLE THAT WAS QUESTIONED BY THE PHYSICIAN. THE CUSTOMER DISCARDED THAT REAGENT PACK AND LOADED A NEW UNPUNCTURED REAGENT PACK ONTO THE INSTRUMENT AND RECALIBRATED. REPEAT TESTING ON A NEW REAGENT PACK GAVE A RESULT OF 1.82NG/ML AND ON AN ALTERNATE METHODOLOGY - THE RESULT WAS "POSITIVE" (ACTUAL RESULT NOT SUPPLIED). THESE RESULTS ABOVE THE AMI CUT-OFF BETTER FIT THE PATIENT'S CLINICAL PICTURE. 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