BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU403-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1775673 · Received July 29, 2010

    Report

    Report Number
    2050012-2010-00526
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 30, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K981473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CALIBRATION, QC, AND PRECISION PERFORMANCE FOR POTASSIUM WERE ACCEPTABLE. THE SERUM SAMPLE WAS COLLECTED IN A SST TUBE, AND PLASMA SPECIMEN WAS DRAWN IN A LITHIUM HEPARIN TUBE. SERVICE WAS NOT DISPATCHED FORT HIS EVENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSELY ELEVATED POTASSIUM (K) RESULTS GENERATED BY THE AU403-02E CHEMISTRY SYSTEM FOR ONE PATIENT SAMPLE. THE ELEVATED RESULTS WERE OBTAINED FROM A SERUM SAMPLE. THE RESULTS WERE REPORTED OUT OF THE LAB AND WERE QUESTIONED. A PLASMA SAMPLE COLLECTED FROM THE PATIENT GAVE LOWER K RESULTS. PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU403-02E CLINICAL CHEMISTRY ANALYZER AU400 CHEMISTRY SYSTEM JJE BECKMAN COULTER MISHIMA K.K. AU400

    Patients

    Seq Age Sex Outcome Treatment
    1