BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE TEST STRIPS

    MDR report key: 1191531 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07199
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K982089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT ADVANTAGE BLOOD GLUCOSE TEST STRIPS WERE LABELED WITH AN EXPIRATION DATE OF 09/2008, AND MISSING THE DIGITS THAT MAKE UP THE DAY PORTION. THE MANUFACTURER'S BATCH RECORDS SHOW THE ACTUAL EXPIRATION DATE TO BE 02/28/02. 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 ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 522566

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR GLUCOVANCE - 1 YEAR 5/500 MG TWICE DAILY