BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1193484 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07427
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 28, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED BLOOD GLUCOSE RESULTS OF HI, WHICH ON THE ADVANTAGE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL, 597 MG/DL AND 191 MG/DL WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED NO SYMPTOMS, DID NOT TREAT OR ACT ON RESULTS. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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 550021

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NEXIUM 40 MG/DAY - 2-3 YEARS| GLUCOPHAGE 2000 MG/DAY - 20 YEARS| GLIPIZIDE 10 MG/DAY - 1 WEEK| ASPIRIN 81 MG/DAY - 6 MONTHS| ACTOS 45 MG/DAY - 5-6 YEARS| CRESTOR 10 MG/DAY - 2-3 YEARS| LIPITOR 20 MG/DAY - 2-3 YEARS