BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 704705 · Received April 24, 2006

    Report

    Report Number
    1823260-2006-01828
    Event Type
    Malfunction
    Date Received
    April 24, 2006
    Date of Event
    April 2, 2006
    Report Date
    April 11, 2006
    Manufacturer
    *
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BLOOD GLUCOSE READINGS HAVE BEEN HIGH RESULTS OF 200-455 MG/DL. IT WAS REPORTED METER READ 504 MG/DL AT 6 PM AND EMERGENCY MEDICAL TECHNICIANS (EMTS) WERE CALLED. REPORTER INDICATED NOT HAVING HIGH GLUCOSE SYMPTOMS AND DID NOT TAKE INSULIN. REPORTER STATED AT 6:10 PM THE EMT METER MEASURED A RESULT OF 104 MG/DL. NO TREATMENT WAS REPORTEDLY REC'D HOWEVER THE EMTS ADVISED CUSTOMER TO TAKE INSULIN AND WAIT HALF HOUR BEFORE EATING. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPALCEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING SYSTEM LFR * NA 548465

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR