BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1110230 · Received August 14, 2008

    Report

    Report Number
    1823260-2007-05186
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES CUSTOMER REPORTEDLY REC'D RESULTS OF 120 MG/DL AND 320 MG/DL WITHIN 10 MINUTES ON THE ACTIVE SYSTEM. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO QUALITY CONTROLS WERE USED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22950931

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR AVANDIA 4MG ONCE DAILY