BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1032709 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03450
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    April 12, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS LTD
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT SHE OBTAINED THE BLOOD GLUCOSE COMPARISON OF 130MG/DL AND 400MG/DL ON THE ACCU-CHEK VOICEMATE SYSTEM. THE RESULTS WERE OBTAINED WITHIN A 10 MINS TIMEFRAME. NO REPORTED SYMPTOMS. THE REPORTER RETESTED AND OBTAINED THE BLOOD GLUCOSE RESULTS OF 120MG/DL AND 170MG/DL ON THE FREESTYLE METER. SHE TREATED HERSELF BASED ON THE FREESTYLE METER RESULTS BY TAKING HER NORMAL DOSE OF INSULIN. THE RESULTS OF TREATMENT UNDISCLOSED. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    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 LTD NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR METHADONE UNK DOSE/FREQ| RIBOFLAVIN UNK DOSE/FREQ| VITAMINS UNK DOSE/FREQ| LANTUS 170 UNITS/DAY| HUMULIN REGULAR 85 UNITS/DAY 2 YRS AND-| SLIDING SCALE| ACTOSE UNK DOSE/FREQ| ALTACE UNK DOSE/FREQ| PROTONIX UNK DOSE/FREQ