BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT TEST DRUM

    MDR report key: 1181144 · Received September 30, 2008

    Report

    Report Number
    1823260-2008-07256
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    September 21, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER EXPERIENCED AN EVENT WHERE HE WAS "OUT OF IT". HIS BLOOD GLUCOSE RESULT WAS 259 MG/DL ON THE ACCU-CHEK COMPACT SYSTEM. FIFTEEN MINUTES LATER HIS BLOOD GLUCOSE RESULT WAS 44 MG/DL ON THE PROFESSIONAL METER. HE WAS TREATED WITH GLUCOSE AND INTRAVENOUS THERAPY (UNK CONTENTS). HE FELT BETTER 2-3 MINUTES FOLLOWING TREATMENT. THE CUSTOMER WAS TAKEN TO THE HOSPITAL. HIS BLOOD GLUCOSE RESULT WAS 100 MG/DL ON THE HOSPITAL'S METER. THE CUSTOMER WAS GIVEN MILK AND WATER. NEW SYSTEM SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS-LFR LFR ROCHE DIAGNOSTICS 20676341

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention PHENTERMINE 3 YEARS| BENAZEPRIL 3-4 YEARS| "SIMDAASTATIN" 3-4 YEARS