BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1122855 · Received August 14, 2008

    Report

    Report Number
    1823260-2008-06219
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED BLOOD GLUCOSE RESULTS OF 213 MG/DL, 308 MG/DL, 205 MG/DL, 134 MG/DL, 120 MG/DL, AND 117 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, REPLACEMENT 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 550632

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR LEVEMIR 14 UNITS/DAY -2 MONTHS| METFORMIN HCL 1500MG/DAY- 2 MONTHS| NOVOLOG 2-3 UNITS/3/DAY -2 MONTHS