BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1780385 · Received September 14, 2007

    Report

    Report Number
    1823260-2007-08086
    Event Type
    Malfunction
    Date Received
    September 14, 2007
    Date of Event
    August 29, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES CUSTOMER REPORTEDLY RECEIVED RESULTS OF 44 MG/DL AND 97 MG/DL WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. NO LOW BLOOD GLUCOSE SYMPTOMS REPORTED WITH THESE RESULTS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT RELATED TO THE DEVICE REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 LFR ROCHE DIAGNOSTICS 549845

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR FEMARA 2.5MG - ONCE DAILY| PREFERVISION 1TAB - 2/DAY| ASPIRIN 81MG - ONCE DAILY| VERAPAMIL 240MG - ONCE DAILY| NOVOLIN N 60UNITS AM/45UNITS - 12 YRS| DARVOCET 100MG - AS NEEDED| DIOVAN 80MG - TWICE DAILY| OS-CAL 500MG - 2-3/DAY| GLUCOSOMINE DOSE UNK - 1-2/DAY| GLUCOPHAGE 500MG - 3/DAY