BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT

    MDR report key: 16784633 · Received April 21, 2023

    Report

    Report Number
    16784633
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    April 11, 2023
    Report Date
    April 14, 2023
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I USED TWO I-STAT EC8+ CARTRIDGES WITH LOT # K23063 TO TAKE MY PATIENT'S BLOOD SUGAR AND POTASSIUM. I WOULD INSERT THE BLOOD AND THE SNAP WOULDN'T LOCK. AFTER A LOT OF FORCE, THE SNAP FINALLY WOULD LOCK AND I WOULD INSERT IT INTO THE I-STAT MACHINE. THE MACHINE WOULD THEN SAY THE CARTRIDGE HAD AN 'ERROR' AND COULDN'T RUN THE LABS. I USED A DIFFERENT LOT # THE THIRD TIME AND HAD NO PROBLEMS WITH THE SNAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792639 I-STAT ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH CHL ABBOTT POINT OF CARE INC. 03P79-25

    Patients

    Seq Age Sex Outcome Treatment
    1 25915 DA Female