BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ANALYZER

    MDR report key: 2222928 · Received July 15, 2011

    Report

    Report Number
    2245578-2011-00114
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT AN I-STAT 1 ANALYZER WAS UNCOMFORTABLY HOT TO TOUCH IN THE BATTERY COMPARTMENT AREA. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ANALYZER I-STAT ANALYZER JJE ABBOTT POINT OF CARE INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1