BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM

    MDR report key: 3022285 · Received March 27, 2013

    Report

    Report Number
    2050012-2013-00191
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    CFR
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS RUN BEFORE THE EVENT WERE WITHIN ACCEPTABLE LIMITS. THE SAMPLES WERE DRAWN IN VACUTAINER SARSTEDT COLLECTION TUBES AND CENTRIFUGED AT 3300 RPMS FOR 10 MINUTES AT AMBIENT TEMPERATURE. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE INSTALLED A NEW GLUCOSE ELECTRODE AND THIS RESOLVED THE ISSUE. THE SAMPLES WERE RERAN ON THE INSTRUMENT AFTER THE NEW ELECTRODE WAS INSTALLED AND YIELDED RESULTS WITHIN THE ACCEPTABLE RANGE. THE FSE CONFIRMED THE GLUCOSE ELECTRODE WHICH WAS REMOVED FROM THE INSTRUMENT WAS WITHIN ON-BOARD DATING AND HAD NOT EXPIRED AT THE TIME OF THE EVENT. THE GLUCOSE ELECTRODE CONTRIBUTED TO THIS EVENT. THE ELECTRODE IS NOT AVAILABLE FOR EVALUATION BY BECKMAN COULTER. FAILURE MODE OF THIS EVENT WAS GLUCOSE ELECTRODE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ONE THOUSAND (1000) ERRONEOUSLY HIGH GLUCOSE MODULE (GLUM) SERUM RESULTS WERE GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEM. THE HIGH GLUM RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. IT HAS BEEN CONFIRMED, BY THE LOCAL FIELD SERVICE ENGINEER (FSE), THAT ALL AFFECTED SAMPLES WERE RERUN ON ANOTHER DXC ANALYZER WHICH YIELDED LOWER GLUM RESULTS AND THESE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER REFUSED TO PROVIDE RESULTS FOR ALL THE SAMPLES INVOLVED. ONLY SEVEN (7) PATIENT SAMPLES WERE PROVIDED BY THE CUSTOMER TO SHOW THE ERRONEOUS GLUCM RESULTS. PATIENT DATA IS PROVIDED IN THE ATTACHMENT. PATIENT AGE AND GENDER INFORMATION WAS NOT SUPPLIED BY THE CUSTOMER. THERE WAS NO EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126338 UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CFR BECKMAN COULTER DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1