BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760870 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-06042
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 24, 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
    CO, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF 77 MG/DL ON HIS ADVANTAGE SYSTEM COMPARED TO THE LAB MEASUREMENT OF 34 MG/DL WHEN TESTING WAS PERFORMED SECONDS APART. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED. 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 549701

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR AVAPRO - 3YRS - 300MG ONCE DAILY| METOPROLOL - 4YRS - 100MG TWICE DAILY| ONCE DAILY| NORVASC - 2YRS - 5MG ONCE DAILY| PLAVIX - 4 YRS - 75MG ONCE DAILY| DILANTIN - 4YRS - 3-100MG ONCE DAILY| HUMALOG - 7 YRS - SLIDING SCALE| CARBAMAZEPINE - 3YRS - 2-200MG TWICE DAILY| ASPIRIN - 4YRS - 81MG ONCE DAILY| VYTORIN - 4YRS - 10/20MG ONCE DAILY| LANTUS - 7YRS - 2 UNITS ONCE DAILY| PROTONIX - 4-5YRS - 40MG ONCE DAILY| ZEMPLAR - COUPLE YRS - 1MCG THREE TIMES WEEKLY| BUMEX - 6YRS - 2&3MG EACH DOSE ONCE DAILY