BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT

    MDR report key: 517060 · Received March 19, 2004

    Report

    Report Number
    1823260-2004-00144
    Event Type
    Injury
    Date Received
    March 19, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 8, 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

    CUSTOMER DID A BLOOD GLUCOSE READING AND RECEIVED A RESULT OF 245 MG/DL. AFTER TAKING MEDICATION THE CUSTOMER PASSED OUT. CUSTOMER WAS TAKEN TO THE HOSPITAL AND WAS ADMITTED. WAS GIVEN AN IV. NO CONTROLS WERE BEING USED AT THE TIME. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE. REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS CORP. NA 20607644

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R