BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 615333 · Received June 16, 2005

    Report

    Report Number
    1823260-2005-01669
    Event Type
    Injury
    Date Received
    June 16, 2005
    Date of Event
    June 4, 2005
    Report Date
    June 6, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE =200 + MG/DL. CUSTOMER WENT TO THE DOCTOR. DOCTOR DEVICE = 109 MG/DL SEVERAL MONTHS AGO AND HE PUT PATIENT ON MEDICATION. CUST0MER WENT TO HOSPITAL AND THEIR DEVICE = 109 MG/DL. NO TREATMENT WAS RECEIVED. NO CONTROLS 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 NA 548117

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization