BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040018 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03820
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 19, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER EXPERIENCED AN EVENT WHERE SHE FELT HYPOGLYCEMIC AND OBTAINED THE BLOOD GLUCOSE RESULT OF 598 MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE REPORTER CALLED THE PARAMEDICS AND THEY TESTED HER AND OBTAINED A BLOOD GLUCOSE RESULT OF 65 MG/DL ON THE PROFESSIONAL METER. THE PARAMEDICS HAD THE REPORTER DRINK JUICE AND EAT SUGAR. THE PARAMEDICS RETESTED HER AND OBTAINED A BLOOD GLUCOSE RESULT OF 64 MG/DL ON THE PROFESSIONAL METER. THE PARAMEDICS TREATED HER WITH AN IV WITH "SUGAR WATER" IN IT. THE REPORTER FELT BETTER AFTER THE FOOD AND IV. THE REPORTER WAS TRANSPORTED TO THE HOSPITAL WHERE HER INITIAL BLOOD GLUCOSE WAS 151 MG/DL ON THE PROFESSIONAL METER. THE HOSPITAL PERSONNEL GAVE HER FOOD TO EAT. NEW SYSTEM SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549631

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention GLUCOPHAGE 2000MG/DAY - 5 YEARS| LASIX UNK DOSE - 2 YEARS-1 TABLET/DAY| CLONIDINE HCL UNK DOSE - 2 YEARS-2 TABLETS/DAY| NOVOLOG 70/30 40 UNITS/DAY - 2 YEARS| METOPROLOL 100MG/DAY - 2 YEARS