BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU643-02E CLINICAL CHEMISTRY ANALYZER

    MDR report key: 1817469 · Received August 26, 2010

    Report

    Report Number
    2050012-2010-00601
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 7, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K961274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS A PLASMA, LITHIUM HEPARIN GREEN TOP WITH SEPARATOR TUBE. CUSTOMER REPORTS NO ISSUES WITH INSTRUMENT OR TESTS AND NO CONTROL ISSUES WERE REPORTED. A FIELD SERVICE ENGINEER (FSE) VISITED AND REPLACED SAMPLE PROBE AND SYRINGE AS A PRECAUTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING BOTH FALSELY HIGH AND LOW RESULTS OF MULTIPLE CHEMISTRIES FOR ONE PATIENT PLASMA SAMPLE GENERATED BY THE AU643-02E CLINICAL CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE ORIGINAL SPECIMENS WERE RE-TESTED, WITHIN ONE HOUR, AND CORRECTED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT IMPACTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU643-02E CLINICAL CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. AU643-02E NA

    Patients

    Seq Age Sex Outcome Treatment
    1