BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 1 ANALYZER

    MDR report key: 2192526 · Received June 30, 2011

    Report

    Report Number
    2245578-2011-00102
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DISTRIBUTOR WHO REPORTED THAT AN I-STAT 1 ANALYZER SHOWED OUT-OF-SPEC STANDBY CURRENT. THE ANALYZER WAS RETURNED TO APOC AND, DURING ROUTINE FAILURE ANALYSIS ON (B)(4) 2011, A BURNT CAPACITOR WAS FOUND. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WAS NO INJURY 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