BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ANALYZER

    MDR report key: 2222925 · Received July 15, 2011

    Report

    Report Number
    2245578-2011-00115
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DIST WHO REPORTED THAT AN I-STAT 1 ANALYZER WOULD NOT ACTIVATE WITH THE POWER KEY. THE ANALYZER WAS RETURNED TO APOC AND, ON (B)(6) 2011, DURING ROUTINE FAILURE ANALYSIS, A BURNED COMPONENT WAS DISCOVERED. 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