BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1000385 · Received February 18, 2008

    Report

    Report Number
    1823260-2008-01624
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED AN ERROR ON THE ADVANTAGE METER WHILE EXHIBITING HYPOGLYCEMIC SYMPTOMS. THE PARAMEDICS WERE CALLED AND RECEIVED A RESULT OF 35 MG/DL ON THEIR DEVICE. CUSTOMER WAS GIVEN AN IV OF UNK CONTENTS. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention DILTIAZEM 360 MG/DAY| GLARGINE 15 MONTHS 60 UNITS/DAY| SIMVASTATIN 40MG/DAY| CHLORTHALIDONE 12.5 MG/DAY