BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2142168 · Received May 26, 2011

    Report

    Report Number
    2122870-2011-01314
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    January 24, 2009
    Report Date
    January 24, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CFR
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE ON (B)(4) 2009. FSE PERFORMED A HIGH SENSITIVITY SYSTEM CHECK AND PASSED WITHIN INSTRUMENT SPECIFICATIONS. CUSTOMER TECHNICAL SUPPORT (CTS) NOTICED THAT THE WASH PERCENT COEFFICIENT OF VARIATION (% CV) BETWEEN THE TWO INSTRUMENT IN THE LAB WAS HIGHER FROM TIME TO TIME AND DECIDED TO SEND IN NEW ASPIRATE PROBES FOR REPLACEMENT. FSE VALIDATED ALL HARDWARE AND IT IS PERFORMING TO PUBLISHED SPECIFICATIONS. ALTHOUGH THE ROOT CAUSE OF THE EVENT IS UNKNOWN, SAMPLE HANDLING MAY BE POSSIBLE CONTRIBUTORY CAUSES TO THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN JANUARY 1, 2008 AND OCTOBER 23, 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC, (BCI) REGARDING A NON-REPRODUCIBLE ACCUTNI (TROPONIN) RESULT IN THE RISK STRATIFICATION RANGE FOR ONE PATIENT. THE RESULTS WERE GENERATED ON A UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER LABORATORY HAS A REPEAT POLICY FOR ALL TROPONIN RESULTS THAT EQUAL OR GREATER THAN 0.04 NG/ML. THE CUSTOMER RE-RAN THE SAMPLE ON ANOTHER INSTRUMENT AND IT WAS WITHIN THE REFERENCE RANGE. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE ARE NO REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENT'S TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CFR BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR ACCESS ACCUTNI