BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 660020 · Received January 3, 2006

    Report

    Report Number
    1823260-2006-00014
    Event Type
    Injury
    Date Received
    January 3, 2006
    Date of Event
    November 4, 2005
    Report Date
    November 20, 2005
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RPTR ALLEGED BLOOD GLUCOSE MONITORING DEVICE WAS GIVING INACCURATE READINGS OVER 200 MG/DL AND BEING ADMITTED TO THE HOSPITAL FOR TWO DAYS WHERE WAS TREATED WITH AN IV AND A SHOT. REPORTER STATED READINGS WERE 194 & 215 MG/DL AND HEART WAS BEATING FAST SO WENT TO THE HOSPITAL WHERE WAS GIVEN THE SHOT TO SLOW HEART RATE AND AN IV, CONTENTS NOT PROVIDED. REPORTER STATED HOSPITAL READING WAS 300 MG/DL. REPORTER INDICATED NOT RUNNING CONTROLS ON THE DEVICE AND A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE BLOOD GLUCOSE NBW ROCHE DIAGNOSTICS NA 3272656

    Patients

    Seq Age Sex Outcome Treatment
    1 *