BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXC 800 PRO SYNCHRON SYSTEM

    MDR report key: 4200441 · Received October 24, 2014

    Report

    Report Number
    2050012-2014-00478
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    CGA
    PMA / PMN Number
    K103842
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND EVALUATED THE INSTRUMENT. THE FSE FOUND THE ACCUSENSE GLUCOSE OXYGEN SENSOR ELECTRODE DAMAGED CAUSED BY CUSTOMER USE ERROR. THE CUSTOMER HAD INCORRECTLY INSTALLED THE ACCUSENSE GLUCOSE OXYGEN SENSOR ELECTRODE DURING MAINTENANCE. THE FSE REPLACED THE ACCUSENSE GLUCOSE OXYGEN SENSOR ELECTRODE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING AN ERRONEOUSLY LOW GLUM (GLUCOSE) RESULT FOR ONE (1) PATIENT, INVOLVING THE UNICEL DXC 800 PRO SYNCHRON SYSTEM. THE RESULT WAS QUESTIONED WHEN THERE WAS A DISCREPANCY BETWEEN THE UNICEL DXC 800 PRO SYNCHRON SYSTEM RESULT AND AN ALTERNATE METHODOLOGY. THE CUSTOMER REPEATED THE SAMPLE ON ANOTHER UNICEL DXC SYSTEM AND OBTAINED A HIGHER GLUM RESULT. THE ERRONEOUSLY LOW GLUM RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT RECEIVED AN IV (INTRAVENOUS) DUE TO THE ERRONEOUSLY LOW GLUM RESULT. QUALITY CONTROL WAS WITHIN LABORATORY'S ESTABLISHED RANGES ON THE DAY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678949 UNICEL DXC 800 PRO SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CGA BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other