BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 517903 · Received March 25, 2004

    Report

    Report Number
    1823260-2004-00177
    Event Type
    Injury
    Date Received
    March 25, 2004
    Date of Event
    March 13, 2004
    Report Date
    March 13, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A RESULT OF 392MG/DL. 10 UNITS OF LANTUS WERE DOSED BASED ON READING. CUSTOMER WENT BACK TO SLEEP. CUSTOMER WAS LATER INCOHERENT AND AN AMBULANCE WAS CALLED AND THEY RECEIVED A READING OF 21MG/DL. CUSTOMER WAS GIVEN AN IV. NO CONTROLS WERE IN USE. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS CORP. NA 522692

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention