BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760871 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-06040
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 19, 2007
    Report Date
    July 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING BLOOD GLUCOSE READINGS OF "HI" TWICE DAILY FOR THE PAST WEEK AND WENT TO HOSPITAL TO TEST GLUCOSE. REPORTER STATED, OBTAINING A BLOOD GLUCOSE RESULT OF "HI" ON HIS ADVANTAGE SYSTEM COMPARED TO THE HOSPITAL MEASUREMENT OF 171 MG/DL WHEN TESTING WAS PERFORMED 5 MINUTES APART. REPORTER INDICATED TAKING NORMAL ORAL DIABETES MEDICATIONS PRIOR TO GOING TO THE HOSPITAL; HOWEVER, NO OTHER ACTIONS WERE TAKEN OR TREATMENT REPORTED AFTER THE TESTING WAS PERFORMED. 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 COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549723

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR GLYBURIDE/METFORMIN HCL - 2MOS - 5MG/500MG| LIPITOR - 2MOS - 5MG ONCE DAILY| TWICE DAILY| LISINOPRIL - 2MOS - 5MG ONCE DAILY