BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1032521 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03431
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    March 14, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CGA
    PMA / PMN Number
    K930979
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HER RELATIVE FOUND HER IN A SEIZURE WHILE SHE WAS SLEEPING AND TRIED USING HER VOICEMATE ADVANTAGE SYSTEM TO TEST HER. REPORTER STATED THAT ONLY AN ERROR COULD BE OBTAINED ON THE DEVICE, SO THE EMTS WERE CALLED, THEY GAVE HER A SHOT AND TOOK HER TO THE HOSPITAL. REPORTER STATED THAT THE HOSPITAL OBTAINED A RESULT OF 106 MG/DL ON THEIR SYSTEM, PUT HER ON THE IV, AND KEPT HER THERE FOR A WEEK. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE - CGA CGA ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R PRANDIN - 1 YEAR / 2MGS 3 TIMES DAILY| LEVEMIR - TIME UNK / 38 UNITS DAILY