BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 12¿ ANALYZER

    MDR report key: 2855218 · Received December 3, 2012

    Report

    Report Number
    1061932-2012-02708
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) CHECKED THE RED BLOOD CELL (RBC) BATH AND PLATE (PLT) COUNT PATHWAY, AND FITTINGS ON THE DILUENT FILTERS. THE FSE VERIFIED REPRODUCIBILITY AND SYSTEM OPERATION AND CONTROLS. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DISCREPANT PLATELET RESULTS, FOR ONE PATIENT, INVOLVING THE COULTER ACT DIFF 12 ANALYZER. THE CUSTOMER STATED PLATELET RESULTS DID NOT CORRELATE UPON RECHECK. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THE CUSTOMER-SUPPLIED DATA INDICATE INITIAL RUN HAD LOW WHITE BLOOD CELL (WBC), PLATELET (PLT) AND ELEVATED RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), AND HEMATOCRIT (HCT) COMPARED TO THE REANALYZED RESULTS. THE INITIAL LOW PLATELET RESULT HAD INSTRUMENT GENERATED FLAG - THE TWO REPEAT RESULTS CORRELATED. THE CUSTOMER ALSO INDICATES MULTIPLE PATIENT SAMPLES WERE AFFECTED BY THE ISSUE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF 12¿ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1