BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4439612 · Received January 22, 2015

    Report

    Report Number
    1061932-2015-00113
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    January 2, 2015
    Report Date
    January 2, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K140911
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON (B)(4) 2015. THE FSE CONFIRMED BUILD UP IN THE HEMOGLOBIN (HGB) CHAMBER CAUSING THE HGB BLANK READING TO RECOVER LOW. THE FSE CLEANED THE HGB CHAMBER, WHICH RESOLVED THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING "HEMOGLOBIN (HGB) BLANK SHIFT" ERRORS ON A UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM, AND REQUESTED A SERVICE VISIT. THE CUSTOMER CONSIDERED THE UNIT TO BE OPERATIONAL. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED 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
    52337 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1