BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770874 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09824
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 25, 2007
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 144MG/DL AND 65MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549821

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR METOPROLOL - 25MG ONCE DAILY - 5 YEARS| HUMULIN - 70/30 15UNITS PM - 5 YEARS| LISINOPRIL - 20MG ONCE DAILY - 5 YEARS| HUMULIN - 70/30 20UNITS AM - 5 YEARS