BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1002670 · Received February 8, 2008

    Report

    Report Number
    1823260-2008-01386
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 26, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT AVIVA BLOOD GLUCOSE TEST STRIPS WERE LABELED WITH AN EXPIRATION DATE OF 2008. THE MFR'S BATCH RECORDS SHOW THE ACTUAL EXPIRATION DATE TO BE 2007. NO ACTIONS OR TREATMENT WERE REPORTED IN CONNECTION WITH THE ALLEGED MALFUNCTION. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    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 300141

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ZETIA - 10-12 YEARS 20MG ONCE DAILY| ACTOS PLUS - 1 YEAR 80MG TWICE DAILY