BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT

    MDR report key: 398746 · Received May 31, 2002

    Report

    Report Number
    2245578-2002-00005
    Event Type
    Malfunction
    Date Received
    May 31, 2002
    Date of Event
    March 15, 2002
    Report Date
    May 30, 2002
    Manufacturer
    *
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED HEMATOCRIT RESULTS FROM I-STAT SYSTEM OF 55% PCV. THIS WAS CONSIDERED NOT CONSISTENT WITH PT'S CONDITION. TEST WAS REPEATED IN LAB AND HEMATOCRIT RESULT WAS 26 %PCV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT I-STAT CARTRIDGE AND ANALYZER CHL * NA D01265

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other