BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1181934 · Received September 22, 2008

    Report

    Report Number
    1823260-2008-07072
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE ACCU-CHEK CURVE STRIP EXPIRATION DATE IS 09/30/2008. THE ELECTRONIC INVENTORY SYSTEM EXPIRATION DATE FOR THE STRIPS IS 06/30/2008. NO ACTIONS TAKEN OR TREATMENT GIVEN BASED ON EVENT. NO ADVERSE EVENT REPORTED. NEW STRIPS SENT 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 549649

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR GLIPIZIDE - 1 YEAR| LANTUS - 2 YEARS| ACTOS - 5 YEARS| LOTENSIN - 2 YEARS| JANUVIA - 1 YEAR