BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF 2 ANALYZER

    MDR report key: 2951127 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00166
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT REQUEST FOR THIS EVENT AND ADDITIONAL INFORMATION, WHICH WAS REQUESTED, WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUS WHITE BLOOD CELL (WBC) RESULTS WITH INSTRUMENT GENERATED FLAGS AND PLATELET (PLT) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS FOR ONE PATIENT INVOLVING A COULTER ACT DIFF 2 ANALYZER. THE CUSTOMER INDICATED THAT THE HEEL STICK SAMPLE WAS RUN IN OPEN VIAL MODE. THE CUSTOMER PROCEEDED TO REPEAT THE SAMPLE TWICE BUT RECEIVED ERRONEOUS WBC AND PLT COUNTS FOR ALL THREE RUNS WHICH WERE DIFFERENT FROM THE HISTORICAL RESULTS OF THE PATIENT. THE ERRONEOUS RESULTS FROM THE LAST RERUN WERE REPORTED OUT OF THE LABORATORY BUT THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A REDRAW WAS MADE ON THE PATIENT AND THE SAMPLE RECOVERED WBC AND PLT RESULTS WHICH WERE CONSIDERED CORRECT. THE WBC RESULT FOR THE REDRAW WAS FLAGGED BUT THE CUSTOMER DEEMED THAT THE WBC RESULT WAS CORRECT FOR THE PATIENT. DATA REVIEW OF THE PROVIDED INSTRUMENT PRINTOUTS INDICATED LOWER RED BLOOD CELL (RBC) AND HEMOGLOBIN (HGB) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS FOR THE INITIAL SAMPLE RESULTS. BOTH THE INITIAL AND REDRAW SAMPLES WERE RUN ON THE ORIGINAL INSTRUMENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED AS SERVICE WAS NOT REQUESTED FOR THIS EVENT. ADDITIONAL INFORMATION FOR THE EVENT CONCERNING ERRORS WHILE RUNNING THE SAMPLE HAD BEEN REQUESTED BUT HAS NOT BEEN PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54637 COULTER® AC*T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1