BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3850169 · Received June 5, 2014

    Report

    Report Number
    1061932-2014-01284
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    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) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE STATED THAT THE 6C CONTROL RESULTS WERE WITHIN SPECIFICATION BUT WERE CONSISTENTLY BELOW THE MEAN ON ALL LEVELS. THE FSE EVALUATED THE INSTRUMENT AND CONFIRMED THAT THE HGB CHAMBER WAS CLOUDY. THE FSE REPLACED THE HGB CHAMBER AND ADJUSTED THE CALIBRATION FACTOR TO RESOLVE THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOW HEMOGLOBIN (HGB) RESULTS ON 6C CONTROLS FROM THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER ALSO STATED THAT THE HEMOGLOBIN (HGB) PARAMETER FAILED THEIR INTERLABORATORY QUALITY ASSURANCE PROGRAM (IQAP). 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
    329630 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1