BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD3200SL 110

    MDR report key: 701885 · Received August 22, 2005

    Report

    Report Number
    2919069-2005-00057
    Event Type
    Other
    Date Received
    August 22, 2005
    Date of Event
    July 25, 2005
    Report Date
    August 18, 2005
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER SUPPORT CENTER (CSC) WAS CONTACTED WITH REGARD TO A LOW HEMOGLOBIN PT RESULT GENERATED USING A CELL-DYN 3200 SL ANALYZER. THE FOLLOWING RESULTS WERE REPORTED TO A PHYSICIAN; RBC=4.58 M/UL, HGB=7.51 G/DL, HCT=38.9%, MCV=84.8FL, MCH=16.4 PG. MCHC=19.3 G/GL. THE CELL-DYN 3200 SL ANALYZER GENERATED AN RBC MORPH FLAG. BASED ON THE LOW HEMOGLOBIN RESULT THE PT WAS HOSPITALIZED. THE HOSPITAL PERFORMED A HEMOGLOBIN TEST (NO PLATFORM PROVIDED) OBTAINING A HGB=13.8 G/DL RESULT. THE PT DID NOT RECEIVE A TRANSFUSION. THE ACCOUNT STATED THAT THE PT WAS SLIGHTLY PSYCHOLOGICALLY TRAUMATIZED BY THE EVENT. NO FURTHER IMPACT TO PT MANAGEMENT WAS RPEORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD3200SL 110 AUTOMATED HEMOATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR