BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD1800 ANALYZER

    MDR report key: 1083850 · Received July 29, 2008

    Report

    Report Number
    2919069-2008-00644
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PT GENERATED A HEMOGLOBIN RESULT OF 8 G/DL ON THE CELL-DYN 1800 ANALYZER AND WAS SENT TO THE HOSP FOR A TRANSFUSION. THE PT WAS REDRAWN AT THE HOSP AND YIELDED A HEMOGLOBIN RESULT OF 10 G/DL (METHOD NOT STATED). A TRANSFUSION WAS NOT INDICATED AND WAS NOT GIVEN. THE ORIGINAL SAMPLE WAS ALSO SENT TO THE HOSP FOR RETESTING AND GENERATED A HEMOGLOBIN RESULT OF 10 G/DL. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI