BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1600 CS

    MDR report key: 54208 · Received December 6, 1996

    Report

    Report Number
    2919069-1996-00002
    Event Type
    Other
    Date Received
    December 6, 1996
    Date of Event
    November 5, 1996
    Report Date
    December 5, 1996
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/CELL DYN
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON 11/5/96, A SUPERVISOR AT THE ACCOUNT REPORTED TWO LOW HGB RESULTS ON TWO ONCOLOGY PTS, WHICH WERE OBTAINED FROM THE DEVICE. BOTH PTS WERE SENT TO THE ER AT THE HOSP ACROSS THE STREET AND REDRAWN. HIGHER HGB RESULTS WERE RECEIVED AT THE HOSP. PT #1 WAS INITIALLY DRAWN BY A HOME HEALTHCARE NURSE AT 0900 AND THE SAMPLE WAS RECEIVED BY THE ACCOUNT AT 1300. RESULTS RECEIVED WERE: HGB=4.7 G/DL;HCT=14.33%. NO CLOTS WERE NOTED IN THE SAMPLE. A HGB RESULT OF 9.6 G/DL WAS RECEIVED AT THE HOSP FROM A NEW SAMPLE. PT #1 WAS RELEASED AND SENT HOME. PT #2 WAS INITIALLY DRAWN BY THE ACCOUNT IN THE AFTERNOON AND THE FOLLOWING RESULTS WERE RECEIVED: HGB=6.9 G/DL; HCT=21.6/21.1%; AND PLT=830-836,000/MM3. PT #2 WAS SENT TO THE SAME ER AND THE FOLLOWING RESULTS WERE RECEIVED: HGB=9.4 G/DL; HCT=29.1%. PT #2 WAS TRANSFUSED AND ADMITTED TO THE HOSP FOR OBSERVATION. POST TRANSFUSION RESULTS, ACCORDING TO THE ACCOUNT, WERE: HGB=9.8 G/DL; HCT=29.8%; 760,000MM3. PT #2 HAS A CLINICAL DIAGNOSIS OF ANEMIA/MYELOPROLIFERATIVE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1600 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIV/CELL DYN NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other