BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1040989 · Received May 8, 2008

    Report

    Report Number
    1823260-2008-03854
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 541 MG/DL ON THE ADVANTAGE SYS COMPARED BACK TO BACK WITH A RESULT OF 88 MG/DL ON THE DOCTOR'S SYS WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT BEFORE THE RESULTS WERE OBTAINED SHE WAS EXPERIENCING SOME HYPOGLYCEMIC SYMPTOMS AND WAS GIVEN RAISINS TO EAT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PROD WAS SENT.

    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 549809

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR ACTOS - 4 YRS| GLYBURIDE - 4YRS| METFORMIN - 4 YRS