BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK

    MDR report key: 600118 · Received May 5, 2005

    Report

    Report Number
    1823260-2005-01102
    Event Type
    Injury
    Date Received
    May 5, 2005
    Date of Event
    April 19, 2005
    Report Date
    April 21, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVICE = 199 MG/DL. CUSTOMER FELT IT WAS LOWER, HOWEVER BOLUSED .04 UNITS OF INSULIN. CUSTOMER WENT TO THE DOCTOR. DOCTOR DEVICE = 89 MG/DL FIFTEEN MINUTES LATER. CUSTOMER WAS GIVEN ORANGE JUICE AND SENT TO ANOTHER DOCTOR FOR TESTING. SECOND DOCTOR DEVICE = 40 MG/DL. CUSTOMER WAS GIVEN A GLUCOSE TABLET AND REMAINED AT THE OFFICE UNTIL BLOOD GLUCOSE ELEVATED. 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 BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention