BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2021258 · Received March 16, 2011

    Report

    Report Number
    2050012-2011-00607
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN GOLD TOP TUBES. QC WAS WITHIN ESTABLISHED RANGES BEFORE THE EVENT. A FIELD SERVICE ENGINEER (FSE) REPLACED REAGENT PROBE "B" WASH COLLAR. THE FSE FOUND LEVEL SENSE BEAD DAMAGED WHICH WAS REPLACED. THE FSE INSPECTED AND CLEANED MIXER WASH STATIONS AND REPAIRED SAMPLE WASH STATION. FSE ALSO FOUND THAT CUVETTES NEEDED ACID WASH, WHICH WAS COMPLETED. THE FSE VERIFIED REPAIR WITH 20 SAMPLE PRECISION FOR REPEATABILITY AND PERFORMED TEST TO VERIFIED ACCURACY. NO ROOT CAUSE WAS IDENTIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW PHOSPHORUS (PHS) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS FOR THREE PATIENTS. THE RESULTS WERE ORR LO, CONFIRMED WITH CUSTOMER THAT THEIR REPORTABLE RANGE WAS 0.5MG/DL. PATIENT SAMPLES WERE SENT TO A REFERENCE LAB FOR REPORTED RESULTS AND THEN RE-CONFIRMED ON THE INSTRUMENT AFTER THE REPAIR. PATIENT RESULTS ARE PROVIDED. THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1