BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1424215 · Received July 28, 2009

    Report

    Report Number
    1823260-2009-05220
    Event Type
    Injury
    Date Received
    July 28, 2009
    Date of Event
    July 18, 2009
    Report Date
    July 29, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K930979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HE WAS CONFUSED AND HYPOGLYCEMIC WHEN HE COULDN'T GET THE ADVANTAGE METER TO POWER ON. REPORTER STATED THAT HE ALSO FELL AND HIS GRANDSON TREATED HIM WITH OJ AND SUGAR. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    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 75 YR Required Intervention LISINOPRIL| GLYBURIDE| METFORMIN| "ATTOVASTIN"| "DILAZTEM"