BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT

    MDR report key: 378603 · Received February 19, 2002

    Report

    Report Number
    MW1024148
    Event Type
    Malfunction
    Date Received
    February 19, 2002
    Date of Event
    January 15, 2002
    Report Date
    February 19, 2002
    Manufacturer
    I-STAT
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MARKED INCREASE IN FAILURE RATE OF I-STAT CARTRIDGES OBSERVED IN LAST MONTH, SUBSTANTIATED ON 1/29/2002. CO NOTIFIED THAT LOT A01159 6+ CARTRIDGES FOR THE POINT OF CARE I-STAT INSTRUMENT WERE GIVING NO DATA FOR POTASSIUM ON UP TO 17 % OF ATTEMPTS (BACKGROUND 1-2 % HERE). DEVICE USED IN A VARIETY OF PT SETTINGS. MOST OF DATA IS CAPTURED IN A DATA MANAGEMENT SYSTEM AND HAS BEEN DOWNLOADED TO THE CO. FAILURE RATE NOT TRACED TO ANY PARTICULAR PT POPULATION. HOSP IS A HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT POINT OF CARE BLOOD GAS AND ELECTROLYTE TEST SYSTEM CHL I-STAT 6 + CARTRIDGE A01189

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other