BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU- CHEK ACTIVE

    MDR report key: 628279 · Received August 9, 2005

    Report

    Report Number
    1823260-2005-02348
    Event Type
    Malfunction
    Date Received
    August 9, 2005
    Date of Event
    July 7, 2005
    Report Date
    July 7, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE = 350 MG/DL. CUSTOMER WAS UNABLE TO FIND THE RESULT IN THE DEVICE MEMORY HOWEVER, WENT TO THE EMERGENCY ROOM (ER) BASED ON THE RESULT. HOSPITAL LAB = 110-117 MG/DL (EXACT VALUE COULD NOT BE RECALLED). TWO - THREE HOURS LATER, HOSPITAL DEVICE = 99 MG/DL. HOSPITAL GAVE CUSTOMER ADDITIONAL MEDICATION TO LOWER BLOOD GLUCOSE. NO CONTROLS WERE USED. 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 ACTIVE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA 22914732

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other