BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 585533 · Received March 25, 2005

    Report

    Report Number
    1823260-2005-00507
    Event Type
    Injury
    Date Received
    March 25, 2005
    Date of Event
    February 11, 2005
    Report Date
    March 1, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER REPORT NUMBER 800273 RECEIVED. SUSPECT DEVICE WAS USED ON A PATIENT WHO ENTERED THE HOSPITAL FOR ELECTIVE THYROID CANCER SURGERY. THE PATIENT WAS ON EXTRANEAL TREATMENT SINCE 12/2003 AND TREATED WITH INSULIN KNOWING THE DEVICE SHOULD NOT BE USED FOR FINGER STICK BLOOD GLUCOSE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention