BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 3822268 · Received May 20, 2014

    Report

    Report Number
    1061932-2014-01122
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND IDENTIFIED THE HEMOGLOBIN CUVETTE REQUIRED REPLACEMENT. THE FSE REPLACED THE HEMOGLOBIN CUVETTE, AND VERIFIED INSTRUMENT PERFORMANCE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR CONDITION OF HEMOGLOBIN INCOMPLETE AND FAILURES OF THE DAILY CHECK WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300795 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1