BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761301 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06378
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    July 6, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES CUSTOMER REPORTEDLY RECEIVED RESULTS OF HI AND 221 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULT. 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 549642

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR LANTUS 55UNITS IN AM - 2.5 YEARS| HUMULIN R SLIDING SCALE - 2.5 YEARS