BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF 2? ANALYZER

    MDR report key: 3192702 · Received June 27, 2013

    Report

    Report Number
    1061932-2013-01291
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE THROUGH SYSTEM TROUBLESHOOTING. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS INCIDENT: 1061932-2013-01260, 1061932-2013-01290, 1061932-2013-01291.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THE CUSTOMER ALLEGED WHITE BLOOD CELL (WBC) FLAG AND VOTE-OUTS FOR TWO PATIENTS, AND ELEVATED INTERMITTENT PLATELET BACKGROUND FOR ONE PATIENT, INVOLVING THE COULTER ACT DIFF 2 ANALYZER. RESULTS FOR THREE PATIENTS WERE PROVIDED SHOWING ERRONEOUS WBC AND DIFFERENTIAL RESULT WITH INSTRUMENT GENERATED MESSAGES. ALL OTHER PARAMETERS WERE COMPARABLE. MAINTENANCE LOG INDICATED SYSTEM STARTUP WAS REPEATED MULTIPLE TIMES ON VARIOUS DAYS DUE TO ELEVATED PLATELET BACKGROUND. NO ERRONEOUS RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER REPLACED THE CHECK VALVES AT THE WBC BATH AND THE RBC (RED BLOOD BLOOD) PORT AS INSTRUCTED BY THE FIELD SERVICE ENGINEER (FSE) AND RESOLVED THE ISSUE. THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292699 COULTER® ACT DIFF 2? ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR