BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD3200 SL 110

    MDR report key: 641474 · Received October 17, 2005

    Report

    Report Number
    2919069-2005-00069
    Event Type
    Other
    Date Received
    October 17, 2005
    Date of Event
    September 27, 2005
    Report Date
    October 14, 2005
    Manufacturer
    ABBOTT DIAGNOSTICS DIV/CELLDYN
    Product Code
    GKP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AN ACCOUNT CONTACTED A COUNTRY SERVICE AND SUPPORT (CSS) WITH REGARD TO A MEDICAL PRACTITIONER QUESTIONING THE HEMOGLOBIN RESULTS FOR A PT. INITIAL RESULTS OF RBC=2.63 M/UL, HGB=5.32 G/DL, MCV=66.3 FL, MCH=20.2 PG, AND MCHC=30.5 G/DL WERE REPORTED USING A CELL-DYN 4000 ANALYZER. LATER THAT SAME DAY THE PT WAS TESTED USING A FRESH SAMPLE ON THE CELL-DYN 3200 SL ANALYZER WITH THE FOLLOWING RESULTS; RBC=2.62 M/UL, HGB=4.04 G/DL, MCV=66.3 FL, MCH=15.4 PG, AND MCHC=23.3 G/GL. BASED ON THE LOWER HEMOGLOBIN RESULT IT WAS ASSUMED THE PT WAS BLEEDING AND A 6 UNIT CROSS MATCH WAS ORDERED AND THE PT WAS TRANSFUSED. THE SAME SAMPLE PREVIOUSLY RAN ON THE CD3200 ANALYZER WAS REPEATED ON THE CD4000 ANALYZER YIELDING; RBC=2.53 M/UL, HGB=5.10 G/DL, MCV=67.0 FL, MCH=20.2 PG, AND MCHC=30.2 G/DL. THE ACCOUNT STATES THAT THE DIFFERENCE IN RESULTS FROM THE TWO ANALYZERS RESULTED IN A MISDIAGNOSIS AND UNNECESSARY TRANSFUSION. THE ACCOUNT BELIEVES THE RESULT FROM THE CELL-DYN 4000 TO BE CORRECT BECAUSE OF THE LOW MCHC RESULT FROM THE CELL-DYN 3200 SL ANALYZER, NO FURTHER IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD3200 SL 110 AUTOMATED HEMATOLOGY ANALYZER GKP ABBOTT DIAGNOSTICS DIV/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other