BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I

    MDR report key: 2083750 · Received May 10, 2011

    Report

    Report Number
    2122870-2011-01357
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    March 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND CENTRIFUGATION DATA WERE NOT SUPPLIED. SYSTEM CHECK DATA WAS NOT SUPPLIED AND CUSTOMER DID NOT PROVIDE INFORMATION INDICATING INSTRUMENT MALFUNCTION. THE LAB HAS SINCE IMPLEMENTED A REPEAT PROTOCOL ON ALL TROPONIN I RESULTS THAT RECOVER GREATER THAN 0.50 NG/ML. SERVICE WAS NOT DISPATCHED, AS CUSTOMER DID NOT QUESTION INSTRUMENT PERFORMANCE. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    WHEN CONTACTED BY BECKMAN COULTER INC. (BCI) REGARDING THE TROPONIN (ACCUTNI) ASSAY PERFORMANCE, THE CUSTOMER STATED THAT THEIR LABORATORY HAD OBTAINED A FALSE POSITIVE ACCUTNI RESULT, GENERATED BY THE UNICEL DXC 600I. THE RESULT WAS REPORTED OUT OF THE LABORATORY. REPEAT TESTING OF THE SAMPLE ON THE SAME INSTRUMENT GENERATED A 'NORMAL' RESULT. THE CUSTOMER STATED THERE WAS NO INSTANCE OF DEATH, INJURY, SERIOUS MEDICAL DETERIORATION, OR INAPPROPRIATE MEDICAL TREATMENT DUE TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I CLINICAL CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. DXC 600I

    Patients

    Seq Age Sex Outcome Treatment
    1