BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 939064 · Received November 5, 2007

    Report

    Report Number
    1823260-2007-09556
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    October 18, 2007
    Report Date
    November 5, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGED OBTAINING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 212, 150, AND 107 MG/DL WHEN ALL TESTS WERE PERFORMED WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED EXPERIENCING HYPOGLYCEMIC SYMPTOMS OF SWEATING AND VISUAL DISTURBANCE. CUSTOMER SELF TREATED BY DRINKING UNSPECIFIED AMOUNT OF ORANGE JUICE, NO OTHER REPORTED ACTIONS WERE TAKEN OR TREATMENT 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 DEVICE LFR ROCHE DIAGNOSTICS 549556

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR LANTUS 3 MONTHS - 16 UNITS ONCE DAILY| HUMALOG 3 MONTHS - 4 OR 5 UNITS 3 TIMES DAILY