BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 770068 · Received August 9, 2006

    Report

    Report Number
    1823260-2006-04276
    Event Type
    Malfunction
    Date Received
    August 9, 2006
    Date of Event
    July 27, 2006
    Report Date
    July 27, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE READINGS WERE ERRATIC WITH RESULTS OF 132, 210, AND 102 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS OF EACH OTHER BACK TO BACK. IT WAS STATED NO ACTIONS WERE TAKEN OR TREATMENT REC'D REPORTEDLY AS A RESULT. 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 BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS * 549103

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR FLUVASTATIN| ACCU-CHEK ADVANTAGE METER| GLIPIZIDE| METFORMIN| ACCU-CHEK COMFORT CURVE CONTROLS| LISINOPRIL| PROSCAR| ROSIGLITAZONE MALEATE| PLAVIX