BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4544075 · Received February 25, 2015

    Report

    Report Number
    1061932-2015-00291
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    January 22, 2015
    Report Date
    January 22, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND INDICATED THAT THE HGB CUVETTE HAD A FILM INSIDE. THE FSE REMOVED THE HGB CUVETTE (CHAMBER) AND CLEANED THE INTERIOR. AFTER CLEANING AND REINSTALLING THE CUVETTE, THE HGB ISSUES WERE RESOLVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HEMOGLOBIN (HGB) VALUES WERE NOT REPRODUCING ON QUALITY CONTROL (QC) AND APPEARED TO BE TRENDING DOWNWARD ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, AND REQUESTED A SERVICE VISIT. THE CUSTOMER TECHNICAL SUPPORT (CTS) REPRESENTATIVE INDICATED THAT THE HGB BLANK WAS UNSTABLE ON THE INSTRUMENT. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132094 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1