BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040020 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03811
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    May 1, 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
    UT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT IN THE 200-299 MG/DL RANGE BACK TO BACK WITH A RESULT OF 17 MG/DL ON THE SAME ADVANTAGE SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS AND PASSED OUT AFTER THE 200-299 MG/DL RESULT. REPORTER STATED HER HUSBAND OBTAINED THE 17 MG/DL RESULT ON HER, CALLED 911, AND SHE WAS TAKEN TO THE HOSPITAL. REPORTER STATED SHE WAS TREATED FOR THAT, AND ALSO SEIZURES UNRELATED TO DIABETES WHILE THERE. 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. REPORTER NO LONGER HAS THE STRIPS USED, AND SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R METFORMIN - 14 YEARS - 500MG TWICE DAILY