BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 541643 · Received March 25, 2004

    Report

    Report Number
    2919069-2004-00012
    Event Type
    Other
    Date Received
    March 25, 2004
    Date of Event
    February 23, 2004
    Report Date
    March 23, 2004
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PHYSICIAN QUESTIONED THE RESULTS OF ONE PT WHOSE RESULTS WERE GENERATED BY THE CELL-DYN 1700 ANALYZER. AN INITIAL HEMOGLOBIN RESULT OF 7.9 G/DL WAS REPEATED AND GENERATED A RESULT OF 11.8 G/DL. CONTROLS RECOVERED WITHIN ACCEPTABLE LIMITS AFTER INITIALLY FAILING. UPON TROUBLESHOOTING, THE ABBOTT CUSTOMER TECHNICAL ADVOCATE (CTA) DISCOVERED THAT THE SAMPLE DRAWN FROM THE PT FILLED LESS THAN ONE-HALF OF THE 5.0 ML COLLECTION TUBE. QUESTIONS ALSO AROSE CONCERNING THE PROPER MIXING AND HANDLING OF CONTROL MATERIAL AND PT SAMPLES. A PRECISION RUN PERFORMED BY THE CUSTOMER (N=10) GAVE ACCEPTABLE RESULTS. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALZYER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN