BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 1 ANALYZER

    MDR report key: 2309433 · Received October 3, 2011

    Report

    Report Number
    2245578-2011-00213
    Event Type
    Malfunction
    Date Received
    October 3, 2011
    Date of Event
    September 22, 2011
    Report Date
    September 22, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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 BECAME HOT TO TOUCH AT THE BATTERY COMPARTMENT. THE CUSTOMER ALSO REPORTED THAT THERE WAS SOME SMOKE COMING FROM THE BATTERY COMPARTMENT PRIOR TO REMOVAL OF BATTERIES. BASED ON THE I NFO 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 1 ANALYZER I-STAT 1 ANALYZER JJE ABBOTT POINT OF CARE INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1