BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 592809 · Received April 13, 2005

    Report

    Report Number
    1823260-2005-00660
    Event Type
    Malfunction
    Date Received
    April 13, 2005
    Report Date
    March 14, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED RUNNING A BLOOD TEST WITHIN THE LAST TWO WEEKS AND DEVICE RESULT = GREATER THAN 600 MG/DL. CUSTOMER STATED NOT THINKING THE RESULT WAS CORRECT AND WENT TO THE DOCTOR. DOCTOR DEVICE = 62 MG/DL. DOCTOR REDUCED INSULIN. DEVICE WAS NOT CODED CORRECTLY. CONTROL INFORMATION WAS NOT PROVIDED. A REQUEST WAS MADE FOR RETURN PRODUCT AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE LFR ROCHE DIAGNOSTICS NA 546637

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other