BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1926983 · Received December 14, 2010

    Report

    Report Number
    2050012-2010-01547
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES. RECALIBRATION RESOLVED THE ISSUE; SERVICE WAS NOT GENERATED. A CLEAR ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) AND REPORTED THAT AFTER MAINTENANCE SODIUM QC WAS WITHIN THE LAB'S ESTABLISHED RANGES ON UNICEL DXC 600 SYNCHRON CLINICAL SYSTEMS, BUT PATIENT NA RECOVERY DRIFTED LOW DURING THE RUN. FALSE LOW NA RESULTS WERE REPORTED OUT OF THE LAB. THE INSTRUMENT WAS RECALIBRATED AND PATIENT SAMPLES WERE RE-TESTED. FORTY (41) PATIENT REPORTS WERE AMENDED. TREATMENT WAS NOT IMPACTED BASED UPON THE FALSE LOW RESULTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1