BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF AL ANALYZER

    MDR report key: 1832883 · Received September 13, 2010

    Report

    Report Number
    1061932-2010-00142
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    August 16, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS WITHIN SPECIFICATION WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A BCI FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE INSTRUMENT DID NOT HAVE THE CORRECT PRINTER DRIVER. SERVICE WAS DISPATCHED TO INSTALL PRINTER DRIVERS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS HIGH WBC AND UNEXPECTED CHARACTER (D) ON THE LEFT SIDE OF THE QBC RESULTS WITHOUT INSTRUMENT GENERATED FLAGS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED TWICE AND SIMILAR RESULTS WERE OBTAINED. THE OPERATOR PERFORMED A MANUAL WBC COUNT TO VERIFY LOW WBC RESULTS. NO DEATH, SERIOUS INJURY, OR PATIENT TREATMENT WAS IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC T 5DIFF AL ANALYZER HEMATOLOGY ANALYZER, GKZ BECKMAN COULTER INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1