BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1181305 · Received September 23, 2008

    Report

    Report Number
    1823260-2008-07104
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 31, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE ACCU-CHEK AVIVA STRIP EXPIRATION DATE IS "2009". THE ELECTRONIC INVENTORY SYSTEM EXPIRATION DATE FOR THE STRIPS IS 11/30/2009. BATCH RECORD VERIFICATION ALSO CONFIRMED THE EXPIRATION DATE AS 11/30/09. 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 AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS- LFR LFR ROCHE DIAGNOSTICS 301358

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK