BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 597437 · Received April 28, 2005

    Report

    Report Number
    1823260-2005-00916
    Event Type
    Injury
    Date Received
    April 28, 2005
    Date of Event
    February 28, 2005
    Report Date
    April 2, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE RESULTS WERE HIGHER THAN NORMAL (250, 289, 300S MG/DL). CUSTOMER TOOK INSULIN. ONE HOUR LATER AT ABOUT 7:15 PM, DEVICE = 28 MG/DL. CUSTOMER WAS GIVEN ORANGE JUICE AND CAKE. CUSTOMER WAS INCOHERENT AND TAKEN TO THE HOSPITAL. HOSPITAL DEVICE = 110 MG/DL. NO OTHER TREATMENT RECEIVED. CONTROL INFORMATION WAS NOT PROVIDED. 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 LFR ROCHE DIAGNOSTICS NA 548447

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R