BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 730414 · Received June 19, 2006

    Report

    Report Number
    1823260-2006-02915
    Event Type
    Malfunction
    Date Received
    June 19, 2006
    Date of Event
    April 5, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED BLOOD GLUCOSE RESULT WAS A "07" ON THE DEVICE WHICH IS OUTSIDE THE READING RANGE OF THE METER. IT WAS STATED ADDITIONAL RESULTS RECEIVED WERE A 169, 397, 150, 397, 165, 297, 171 & 407 MG/DL. NO ACTIONS OR TREATMENT RESULTED REPORTEDLY. 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 TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS NA 548723

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ACCU-CHEK ADVANTAGE METER