BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1253185 · Received December 5, 2008

    Report

    Report Number
    1823260-2008-08956
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    December 3, 2008
    Report Date
    December 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K930979
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ATTEMPTED TO USE THE ADVANTAGE DEVICE BUT FOUND IT HAD NO POWER. THE PARAMEDICS WERE CALLED AND TESTED CUSTOMER AT 42MG/DL ON THEIR DEVICE. CUSTOMER WAS GIVEN GLUCOSE GEL. REQUESTED RETURN OF 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 - CGA CGA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention HUMULIN 56 UNITS/DAY