BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF 2 ANALYZER

    MDR report key: 3962236 · Received July 28, 2014

    Report

    Report Number
    1061932-2014-01784
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND CONFIRMED THE HEMOGLOBIN HOLDER WITH PHOTO DIODE WAS FAULTY. THE FSE REPLACED THE HEMOGLOBIN HOLDER WITH PHOTO DIODE RESOLVING THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT ERRATIC HEMOGLOBIN (HGB) RESULTS AND H&H (HEMOGLOBIN & HEMATOCRIT) CHECK FAILURES ON PATIENT RESULTS WHEN USING THE COULTER ACT DIFF 2 ANALYZER. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY AND NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439379 COULTER ACT DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1