BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 1052952 · Received May 27, 2008

    Report

    Report Number
    2050012-2008-00023
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 27, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN SPECIFICATIONS BEFORE AND AFTER THE EVENT. THE SPECIMEN WAS COLLECTED IN A GREEN TOP VACUTAINER TUBE. NO OTHER CHEMISTRIES FOR THIS PT WERE RERUN OR QUESTIONED. CUSTOMER INDICATED THAT THIS WAS AN ISOLATED EVENT AND NO OTHER SAMPLES HAVE TRIGGERED CRITICAL RERUN PRIOR TO THE EVENT. PER CUSTOMER, GLUCOSE ELECTRODE WAS LEFT ON THE INSTRUMENT BEYOND THE BCI RECOMMENDED SIX MONTHS MAINTENANCE REPLACEMENT POLICY. CUSTOMER REPLACED THE GLUCOSE ELECTRODE PRIOR TO CALLING HOTLINE. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE REPLACED GLUCOSE STIRRER MOTOR AFTER OBSERVING THE MOTOR STALLING DURING OPERATION. MOTOR WAS INADVERTENTLY DISCARDED AND WILL NOT BE RETURNED TO BCI. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE HIGH GLUCOSE (GLUM) RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYS FOR A SINGLE PT. THE INITIAL GLUM RESULT OF 481MG/DL TRIGGERED A CRITICAL RERUN AT THE INSTRUMENT AND REPEATED RESULT WAS 123MG/DL. THE ORIGINAL SAMPLE WAS TESTED FOR GLU ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB AND A RESULT OF 120MG/DL WAS OBTAINED. THE RESULT OF 123MG/DL WAS REPORTED OUT OF THE LAB. PT TREATMENT WAS NOT INITIATED OR WITHHELD BECAUSE THE ELEVATED GLUM RESULT WAS NOT REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA