BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1040948 · Received May 2, 2008

    Report

    Report Number
    1823260-2008-03715
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    April 9, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THE EXPIRATION DATE ON THE ACCU-CHEK AVIVA TEST STRIPS IS 08/31/08. THE MFR'S EXPIRATION DATE IS 8/31/07. NO REPORTED ACTIONS TAKEN. NO ADVERSE EVENT REPORTED. NEW STRIPS SENT AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR NBW ROCHE DIAGNOSTICS 300205

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR GLUCOPHAGE 200MG/DAY 6 MONTHS| "NOVOLOG 75/25" SLIDING SCALE 2.5 YRS