BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1123937 · Received August 15, 2008

    Report

    Report Number
    1823260-2008-06261
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    April 1, 2006
    Report Date
    August 15, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK ADVANTAGE SYSTEM 2. REFERENCE MEDWATCH FOR SUSPECT DEVICE ACCU-CHEK ADVANTAGE SYSTEM 1.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY OBTAINED A 450 MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM 1 IN COMPARISON TO THE BLOOD GLUCOSE RESULT TO 202MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM 2. THE RESULTS WERE OBTAINED WITHIN A TEN MINUTE TIMEFRAME. NO REPORTED ACTIONS TAKEN OR TREATMENT RENDERED. 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 550643

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR GLIPIZIDE