BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1180207 · Received September 29, 2008

    Report

    Report Number
    1823260-2008-07230
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CALLER REPORTS THAT THE CUSTOMER FELT SHAKY. SHE WAS NOT SURE IF THE CUSTOMER WAS HYPOGLYCEMIC OR HYPERGLYCEMIC. THE CUSTOMER ATTEMPTED TO TEST ON THE ACCU-CHEK ADVANTAGE SYSTEM AND RECEIVED AN "EEE". THE CUSTOMER WAS TESTED ON THE PROFESSIONAL METER WITH A BLOOD GLUCOSE RESULT OF 223MG/DL. THE CALLER STATES THAT SHE WAS GOING TO TREAT THE CUSTOMER WITH INSULIN. THE CALLER DID NOT CONFIRM IF THE CUSTOMER RECEIVED THE INSULIN. NEW SYSTEM SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention