BEUDAMED
    FDA Adverse Event Other Summary report: N

    CD 3700 SL

    MDR report key: 514294 · Received January 14, 2004

    Report

    Report Number
    2919069-2004-00002
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    December 19, 2003
    Report Date
    January 13, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 3700 ANALYZER IS GENERATING INTERMITTENT ERRATIC RESULTS. A PATIENT RESULT WAS REPORTED FROM THE LAB WITH A HEMOGLOBIN RESULT OF 10.7 G/DL. THE CUSTOMER NOTICED THAT SEVEN SAMPLE VALUES ON THE SAMPLE RACK ALL HAD FLAGGED RESULTS. THE SAMPLES WERE REPEATED AND THE SAMPLE NOTED PREVIOUSLY RETESTED WITH A HEMOGLOBIN RESULT OF 8.78 G/DL. THE SAMPLE WAS REPEATED ON ANOTHER CELL-DYN 3700 ANALYZER IN THE LAB WITH A GENERATED HEMOGLOBIN RESULT OF 8.8 G/DL. CONTROLS REMAINED WITHIN SPECIFICATIONS. THE CUSTOMER TRIED A NUMBER OF TROUBLESHOOTING PROCEDURES THAT DID NOT RESOLVE THE ISSUE. THE CUSTOMER REQUESTED A SERVICE CALL. THERE IS NO IMPACT TO PAIENT 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 78 YR CELL-DYN 3700 ANALYZER CATALOG NO. 2H31-01.