BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® IMMUNOASSAY CLINICAL SYSTEM

    MDR report key: 2151817 · Received July 6, 2011

    Report

    Report Number
    2122870-2011-01177
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    March 25, 2010
    Report Date
    April 1, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC, CALIBRATION, AND SYSTEM CHECK DATA WERE NOT PROVIDED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER WAS NOT QUESTIONING INSTRUMENT PERFORMANCE. A SAMPLE FROM THE PATIENT WAS SENT TO BCI FOR ROOT CAUSE INVESTIGATION. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED. NOTE: SIMILAR EVENTS ON THE SAMPLES FROM THIS PATIENT ARE REPORTED IN REPORT #2122870-2011-01175 AND 2122870-2011-01176. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED TROPONIN (ACCUTNI) RESULTS, ABOVE THE AMI CUTOFF, GENERATED BY ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® IMMUNOASSAY CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR