BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK COMFORT CURVE TEST STRIPS

    MDR report key: 1022674 · Received April 1, 2008

    Report

    Report Number
    1823260-2008-02919
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 12, 2008
    Report Date
    April 1, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT PT (#3) WAS TESTED WITH A BLOOD GLUCOSE RESULT OF 67 MG/DL ON THE ACCU-CHEK INFORM SYSTEM IN COMPARISON TO A LAB RESULT OF 37 MG/DL. AN ADD'L COMPARISON (PT #3) WAS OBTAINED WITH THE BLOOD GLUCOSE RESULT OF 79 MG/DL ON THE ACCU-CHEK INFORM SYSTEM IN COMPARISON TO A LAB RESULT OF 46 MG/DL. EACH COMPARISON WAS OBTAINED WITHIN A TEN MINUTE TIMEFRAME. THE PT'S IV RATE WAS INCREASED BASED ON THE RESULTS. NO ADVERSE EVENT REPORTED. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549729

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK