BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 517921 · Received March 25, 2004

    Report

    Report Number
    1823260-2004-00176
    Event Type
    Injury
    Date Received
    March 25, 2004
    Date of Event
    March 5, 2004
    Report Date
    March 9, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER TOOK A BLOOD GLUCOSE READING AND RECEIVED A RESULT OF 539MG/D. CUSTOMER WAS DOSED BASED ON READING. RETESTED AND RECEIVED A RESULT OF 500MG/DL. ONE HOUR LATER THE AMBULANCE WAS CALLED AND THEY RECEIVED A RESULT OF 15MG/DL. CUSTOMER WAS TAKEN TO THE HOSP AND RECEIVED A SHOT OF GLUCOGEN. CUSTOMER STATES THAT CONTROLS WERE IN RANGE. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS CORP. NA 546829

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening| R