BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 772857 · Received August 14, 2006

    Report

    Report Number
    1823260-2006-04447
    Event Type
    Malfunction
    Date Received
    August 14, 2006
    Date of Event
    August 1, 2006
    Report Date
    August 4, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE READINGS HAVE BEEN HIGHER FOR THE PAST TWO WEEKS OF 120-160 MG/DL. IT WAS STATED ON ONE EVENING AT 8 PM GLUCOSE MEASURED 325, 222, 303, AND 153 MG/DL WHEN ALL TESTS WERE PERFORMED "RIGHT AWAY" ONE AFTER THE OTHER. NO ACTIONS OR TREATMENT WAS REC'D AS A RESULT. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT 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 CFR ROCHE DIAGNOSTICS * 549119

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR GLUCOVANCE.| LIPITOR| ACCU-CHEK ADVANTAGE METER