BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 620483 · Received July 7, 2005

    Report

    Report Number
    1823260-2005-01887
    Event Type
    Injury
    Date Received
    July 7, 2005
    Date of Event
    June 24, 2005
    Report Date
    June 24, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE = 365 MG/DL. CUSTOMER WAS TEKEN TO THE HOSP AND THEIR DEVICE = 147 MG/DL. NO TREATMENT WAS RECEIVED. CONTROLS WERE USED BUT NOT CERTAIN IF VALUES ARE WITHIN RANGE. 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 COMPACT BLOOD GLUCOSE MONITORING DEVICE NBN ROCHE DIAGNOSTICS NA 20623744

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization