BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761214 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06401
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 9, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED WHEN GOING TO A ROUTINE DOCTOR APPOINTMENT, OBTAINING A RESULT OF 222 MG/DL ON HIS ADVANTAGE SYSTEM COMPARED TO THE DOCTOR'S MEASUREMENT OF 94 MG/DL WHEN TESTING WAS PERFORMED A FEW SECONDS APART. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED RECEIVED. 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 549644

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR VANDIA - 4 YRS, 8MG TWICE DAILY| GLIPIZIDE - 4 YRS, 10M/G ONCE DAILY