BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 685838 · Received February 27, 2006

    Report

    Report Number
    1823260-2006-00843
    Event Type
    Injury
    Date Received
    February 27, 2006
    Date of Event
    February 3, 2006
    Report Date
    February 6, 2006
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED GLUCOSE READ 450= MG/DL AND AN AMBULANCE WAS CALLED BY S RELATIVE DUE TO NO BEING ABLE TO GET HER PT TO REACT. IT WAS REPORTED EMERGENCY MEDICAL TECHNICIANS (EMT'S) MEASURED 44 MG/DL FIVE MINUTES LATER. REPORTER STATED EMT'S TREATED CUSTOMER WITH "SUGAR WATER" AND ADMITTED TO THE HOSP. NO GLUCOSE READINGS WERE REPORTED FROM THE HOSP. HOWEVER WAS TREATED WITH 2 GLUCOSE IV'S AND ANOTHER IV, CONTENTS UNK. 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 MONITORING SYSTEM NBW ROCHE DIAGNOSTICS CORP. NA 22923431

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| L| R