BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT THERMAL ANALYZER

    MDR report key: 2142635 · Received June 21, 2011

    Report

    Report Number
    2245578-2011-00090
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    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 DISTRIBUTOR WHO REPORTED THAT, DURING ROUTINE FAILURE ANALYSIS OF AN I-STAT ANALYZER, A BURNED COMPONENT WAS DISCOVERED. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1