BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD 3700 SL

    MDR report key: 514295 · Received January 14, 2004

    Report

    Report Number
    2919069-2004-00001
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    December 18, 2003
    Report Date
    January 13, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ERRATIC PATIENT RESULTS ARE BEING GENERATED BY THE CELL-DYN 3700 ANALYZER. THE CUSTOMER GIVES THE EXAMPLE OF PATIENT HEMOGLOBIN INITIALLY READING 9.9 G/DL THAT REPEATED AT 15.9, 13.0 AND 8.9 G/DL. THE SAMPLE WAS REPEATED ON THE BACK-UP CELL-DYN ANALYZER WITH RESULTS MATCHING THE INITIAL HEMOGLOBIN RESULT OF 9.9 G/DL. CONTROLS WERE WITHIN SPECIFICATIONS. THE CUSTOMER IS REQUESTING A SERVICE CALL. THE CUSTOMER WILL NOT PROVIDE ANY FURTHER PATIENT INFO. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD 3700 SL AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO