BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1600 CS

    MDR report key: 479007 · Received August 12, 2003

    Report

    Report Number
    2919069-2003-00018
    Event Type
    Other
    Date Received
    August 12, 2003
    Date of Event
    July 15, 2003
    Report Date
    August 11, 2003
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELL DYN
    Product Code
    GKZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE CELL-DYN 1600 ANALYZER GENERATED PLATELET RESULTS ON ONE PATIENT OF 3.7 K/UL, 5.0 K/UL AND 3.8 K/UL. CONTROLS WERE WITHIN SPECIFICATIONS. RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE SAMPLE WAS SENT TO A HOSPITAL LABORATORY WHERE A RESULT OF 385 K/UL WAS GENERATED. THE CUSTOMER WOULD NOT PROVIDE ANY PATIENT INFORMATION. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1600 CS AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELL DYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN