BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 875560 · Received September 12, 2006

    Report

    Report Number
    1823260-2006-05009
    Event Type
    Malfunction
    Date Received
    September 12, 2006
    Date of Event
    August 28, 2006
    Report Date
    August 29, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE MEASURED 213, 115, AND 110 MG/DL WHEN ALL TESTS WERE PERFORMED BACK TO BACK WITHIN A FEW MINUTES OF EACH OTHER. IT WAS STATED CUSTOMER DID NOT HAVE ANY SYMPTOMS AT THE TIME. NO ACTIONS WERE TAKEN OR TREATMENT RESULTED WAS REPORTED. 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 COMFORT CURVE BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS * 548989

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR LANTUS| GLIPIZIDE| ACCU-CHEK ADVANTAGE METER