BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2 ANALYZER

    MDR report key: 1961529 · Received January 14, 2011

    Report

    Report Number
    1061932-2011-00030
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN A 4ML EDTA VACUTAINER TUBE AND SAMPLED WITHIN 3-4 MINUTES AFTER BEING DRAWN. THE SPECIMEN WAS STORED AT ROOM TEMPERATURE. QC WAS RUN BEFORE THE EVENT AND RESULTS RECOVERED WITHIN ASSAY RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE BLEACHED THE SYSTEM AND SET AIMS. THE FSE VERIFIED THE INSTRUMENT. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY HIGH HEMOGLOBIN (HGB) RESULT GENERATED BY THE COULTER AC-T DIFF 2 ANALYZER FOR ONE PATIENT. THE PATIENT WAS REDRAWN AND REPEATED HGB RESULT WAS LOWER. THE ERRONEOUS HGB RESULT WAS NOT REPORTED OUT OF THE LAB. BASED ON THE AVAILABLE INFORMATION, PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC T DIFF 2

    Patients

    Seq Age Sex Outcome Treatment
    1