BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 743031 · Received July 6, 2005

    Report

    Report Number
    1823260-2005-01850
    Event Type
    Malfunction
    Date Received
    July 6, 2005
    Date of Event
    June 17, 2005
    Report Date
    June 20, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED PT WAS IN THE EMERGENCY ROOM (ER) FOR A HEART ATTACK. DEVICES = 151, 163, & 157 MG/DL AND LAB = 237 & 238 MG/DL PERFORMED 10 MINUTES OF EACH OTHER. CONTROLS WERE IN RANGE. TREATMENT INFORMATION WAS NOT PROVIDED . A REQUEST WAS MADE FOR RETURN PRODUCT, HOWEVER REPLACEMENT WAS DECLINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA 548494

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other