BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT

    MDR report key: 399351 · Received June 7, 2002

    Report

    Report Number
    2245578-2002-00007
    Event Type
    Malfunction
    Date Received
    June 7, 2002
    Date of Event
    May 9, 2002
    Report Date
    June 6, 2002
    Manufacturer
    I-STAT CORP.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT HEMOGLOBIN AND HEMATOCRIT RESULTS FROM I-STAT SYSTEM AS COMPARED TO LABORATORY RESULTS. I-STAT SYSTEM HGB RESULT OF 0G/DL/HCT 1% PCV. REPEAT TESTING ON LABORATORY ANALYZER HGB 4.3 G/DL, HCT 13% PCV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT I-STAT CARTRIDGE AND ANALYZER CHL I-STAT CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other