BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1190631 · Received October 6, 2008

    Report

    Report Number
    1823260-2008-07383
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ACCU-CHEK ADVANTAGE SYSTEM WITHIN 10 MINUTES: 307 MG/DL, 175MG/DL, 150 MG/DL, AND 120 MG/DL. 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550693

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR LANTUS - 13 YEARS| HUMALOG - 13 YEARS| ACTOS