BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 596892 · Received April 26, 2005

    Report

    Report Number
    1823260-2005-00805
    Event Type
    Injury
    Date Received
    April 26, 2005
    Date of Event
    March 28, 2005
    Report Date
    March 29, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE = 400 MG/DL. CUSTOMER CALLED EMERGENCY MEDICAL RESOURCE (EMR). EMR DEVICE =200 MG/DL. CUSTOMER WAS TREATED BUT WAS NOT SURE WHAT TYPE WAS PROVIDED. NO CONTROLS WERE USED. A REQUEST WAS MADE FOR RETURN PRODUCT 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 548380

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention