BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1772084 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09518
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 15, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE PATIENT OBTAINED A DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULT OF 513 MG/DL ON THE INFORM SYSTEM. THE TEST WAS PERFORMED WITHIN 10 MINUTES OF LAB BLOOD GLUCOSE READINGS OF 203 MG/DL AND 208 MG/DL. REPORTER INDICATED THE PATIENT WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO OTHER ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT 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 TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549710

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR