BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 1 ANALYZER

    MDR report key: 1821342 · Received August 26, 2010

    Report

    Report Number
    2245578-2010-00109
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT 1 ANALYZER WAS HOT TO TOUCH. BASED ON THE INFO AT THE TIME, THERE WAS NO INJURY ASSOCIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1