BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4624892 · Received March 23, 2015

    Report

    Report Number
    1061932-2015-00506
    Event Type
    Malfunction
    Date Received
    March 23, 2015
    Date of Event
    February 25, 2015
    Report Date
    February 26, 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, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE CONFIRMED THE HGB DAILY CHECK FAILURES AND REPLACED THE HGB CHAMBER ASSEMBLY PN 629029, DUE TO A CLOUDY APPEARANCE, RESOLVING THE HGB DAILY CHECK FAILURES; THE INSTRUMENT WAS VERIFIED BY RUNNING REPEATABILITY, CARRYOVER AND CONTROLS, AND DAILY CHECKS WHICH ALL PASSED VERIFICATION. WEIGHT WAS NOT PROVIDED FOR PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HEMOGLOBIN (HGB) CARRYOVER FAILURE ON A UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM; HGB DAILY CHECK FAILURES WAS ALSO NOTED ON THE CONTROL PRINT OUTS. ADDITIONALLY, THE CUSTOMER INDICATED THAT ERRONEOUS RESULTS WERE OBTAINED ON A SINGLE SAMPLE RUN THROUGH THE ANALYZER, COMPARED TO RESULTS OBTAINED BY REPEAT RERUN ON THE SAME INSTRUMENT, WHICH WERE REPORTED AS CORRECT. SAMPLES WERE COLLECTED IN 4.5ML EDTA CONTAINERS; THE CUSTOMER DID NOT QUESTION SAMPLE INTEGRITY FOR THIS EVENT. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY 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
    193257 UNICEL DXH 600 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR