BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA

    MDR report key: 672709 · Received February 3, 2006

    Report

    Report Number
    1823260-2006-00406
    Event Type
    Malfunction
    Date Received
    February 3, 2006
    Date of Event
    September 26, 2005
    Report Date
    December 26, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED DOSING INSULIN, AMOUNT NOT PROVIDED, BASED ON READINGS OF 520, 147, 480, 240, 375, AND 190 MG/DL. REPORTER STATED GOING TO THE HOSP AND BEING ADMITTED FOR CONDITIONS UNRELATED TO DIABETES. REPORTER STATED BEING TREATED WITH AN IV, CONTENTS UNK, AND OTHER NON-DIABETES RELATED TESTING PERFORMED. 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 AVIVA BLOOD GLUCOSE MONITORING SYSTEM NBW ROCHE DIAGNOSTICS CORP. NA 300076

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR