BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 507833 · Received January 22, 2004

    Report

    Report Number
    1823260-2004-00029
    Event Type
    Injury
    Date Received
    January 22, 2004
    Date of Event
    January 14, 2004
    Report Date
    January 15, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER WOKE UP WITH HYPOGLYCEMIC SYMPTOMS AND CHECKED THEIR GLUCOSE ON THE DEVICE. CUSTOMER OBTAINED A READING OF 108 MG/DL. CUSTOMER WENT TO THE HOSP AND THEIR GLUCOSE WAS 40 MG/DL. CUSTOMER WAS ADMITTED AND TREATED FOR HYPOGLYCEMIA. CUSTOMER SAID CONTROLS WERE IN RANGE ON THE SYSTEM. THE DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS CORP. NA 546820

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention