BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2114189 · Received June 6, 2011

    Report

    Report Number
    2050012-2011-02073
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GLUCM QC IS WITHIN 2SD OF CUSTOMER'S ESTABLISHED RANGES FOR ALL 3 LEVELS. BCI SERVICE REPLACED THE GLUCOSE REAGENT SYRINGE, CLEANED THE CUP AND REAGENT LINES, AND INSTALLED A NEW ELECTRODE. NO NEW INCIDENTS FOR GLUCOSE SEEN TO DATE SINCE REPAIRS WERE PERFORMED. ALTHOUGH PARTS WERE REPLACED, ROOT CAUSE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER INC. (BCI) THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER GENERATED ERRONEOUSLY LOW GLUCOSE (GLUCM) RESULTS FOR TEN (10) PATIENTS. THESE RESULTS WERE REPORTED OUT OF THE LAB. REPEAT TESTING ON THE SAME INSTRUMENT GENERATED HIGHER RESULTS. RESULTS ARE SHOWN. CUSTOMER CONFIRMED THERE WAS NO EFFECT ON PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1