BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2991834 · Received March 6, 2013

    Report

    Report Number
    1061932-2013-00283
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CTS (CUSTOMER TECHNICAL SUPPORT) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND FOUND THE HGB GAIN WAS ADJUSTED TO THE MAXIMUM LIMIT (255). THE CUSTOMER DECLINED SERVICE STATING THAT THEY WERE AWAITING SERVICE FROM THEIR LOCAL BIOMEDICAL ENGINEER. A CLEAR CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT ERRONEOUS LOW HEMOGLOBIN (HGB) RESULTS ON FIVE (5) FINGER STICK SAMPLES GENERATED BY A COULTER ACT DIFF ANALYZER. THE PATIENTS WERE DRAWN VIA VENIPUNCTURE AND RUN ON A REFERENCE INSTRUMENT WHERE HGB WAS CONSIDERED CORRECT AND REPORTED OUT. THE ERRONEOUS LOW HGB RESULTS ARE SHOWN IN THE ATTACHMENT. ONLY ONE HGB RESULT DISPLAYED AN INSTRUMENT GENERATED FLAG. CORRESPONDING CORRECT RESULTS FROM THE REFERENCE LAB WERE NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96300 COULTER® ACT DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER ACT DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1