BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1771185 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01252
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S GRANDDAUGHTER REPORTS BACK TO BACK ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 250MG/DL AND 108MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    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 549848

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR FUROSEMIDE - 40MG| GLUCOPHAGE - 500MG 2X/DAY| COREG - 6.25MG/DAY| CRESTOR - 10MG/DAY| KLOR-CON - 8MG/DAY| ASPIRIN - 81MG/DAY| ZETIA - 10MG