BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CENTRAL DATA STATION

    MDR report key: 1893963 · Received November 3, 2010

    Report

    Report Number
    2245578-2010-00145
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    CDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THAT THE I-STAT 1 ANALYZER PROVIDED A CORRECT GLUCOSE RESULT BUT WHEN ATTACHED TO THE I-STAT CENTRAL DATA STATION THE IDENTIFICATION NUMBER CHANGED FROM THE ORIGINAL ENTERED IDENTIFICATION NUMBER, CURRENTLY FOR UNKNOWN REASONS. THERE WAS NO REPORT OF ANY INJURY OR IMPACT TO PATIENT CARE ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION IS BEING REQUESTED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CENTRAL DATA STATION CDS ABBOTT POINT OF CARE INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA