BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2535765 · Received April 13, 2012

    Report

    Report Number
    2122870-2012-01003
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    March 18, 2012
    Report Date
    March 19, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (DXC 600I) GENERATED AN ERRONEOUS TROPONIN I (ACCUTNI) RESULT ON ONE PATIENT SAMPLE. CUSTOMER REPORTED THAT ACCESS ACCUTNI REAGENT, LOT 118473, AND ACCESS ACCUTNI CALIBRATORS ((B)(4)), LOT 121451, WERE USED IN CONJUNCTION WITH THE DXC 600I ANALYZER. CUSTOMER REPORTED THAT THE ERRONEOUS RESULT WAS REPORTED OUT OF THE LABORATORY. CUSTOMER REPORTED THAT THE RESULT WAS CORRECTED. CUSTOMER REPORTED THAT THERE WAS NO CHANGE IN PATIENT TREATMENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) REPLACED A BENT ASPIRATE PROBE WITH A NEW COMPLETE SET AND CORRECTED PIPETTOR ALIGNMENT TO THE REACTION VESSEL SHUTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR