BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1080532 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05626
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 22, 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 STATES THAT SHE CAN'T SEE WELL AND THE ACCU-CHEK COMFORT CURVE STRIPS EXPIRATION DATE MAY BE 7/31/2009 OR 1/31/2009. THE ELECTRONIC INVENTORY SYSTEM EXPIRATION DATE FOR THE STRIPS IS 1/31/2009. BATCH RECORD VERIFICATION CONFIRMED THE EXPIRATION DATE IS 1/31/2009. NO ACTIONS TAKEN OR TREATMENT GIVEN BASED ON EVENT. 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 549944

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR PAIN PILLS 1 MONTH| BLOOD PRESSURE PILLS| "N"| HEART PILLS 10 YEARS| "R"| "7030"