BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK

    MDR report key: 517030 · Received March 19, 2004

    Report

    Report Number
    1823260-2004-00130
    Event Type
    Injury
    Date Received
    March 19, 2004
    Date of Event
    August 6, 2001
    Report Date
    March 2, 2004
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 150MG/DL, TOOK NORMAL AMOUNT OF INSULIN. WAS UNRESPONSIVE THE NEXT MORNING AND WAS IN A COMA STATE. CUSTOMER'S FAMILY MEMBER WAS ABLE TO WAKE THEM AND THEY BECAME VIOLENT. PARAMEDICS WERE CALLED AND TESTED BLOOD GLUCOSE AND RECEIVED A READING OF 125MG/DL ON THE SAME DEVICE. CUSTOMER WAS TAKEN TO THE HOSPITAL AND GIVEN SHOT TO CALM THEM DOWN. THE HOSPITAL TESTED THEIR BLOOD GLUCOSE (UNSURE OF THE RESULT). THEY WERE GIVEN JUICE. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening| R