BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 4260351 · Received November 18, 2014

    Report

    Report Number
    2050012-2014-00498
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE CONFIRMED A LEAK FROM THE SAMPLE PROBE INTO THE DRIP TRAY WHEN THE PROBE WAS WASHED OR PRIMED. THE FSE REPLACED MULTIPLE PARTS TO CORRECT THE LEAK AND CALIBRATION FAILURE AND WAS UNABLE TO ASSIGN A CAUSE FOR THE LEAK. THE FSE REPLACED THE T-VALVE, COLLAR WASH VALVE, COLLAR WASH AND SAMPLE PROBE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) HOTLINE SUPPORT THAT FLUID WAS OBSERVED ON THE TIP OF THE CARTRIDGE CHEMISTRY (CC) SAMPLE PROBE AND MULTIPLE ANALYTES FAILED CALIBRATION ON THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM WHILE COMPLETING MAINTENANCE. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. NO DIRECT EXPOSURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744293 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1