BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1802435 · Received August 17, 2010

    Report

    Report Number
    1823260-2010-04870
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 400 MG/DL AND 178 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER STATES TEST STRIP VIAL CAP IS NOT ON TIGHT. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND 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 ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR HUMALOG 75/25| CADUET| METFORMIN