BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770837 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09841
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 24, 2006
    Report Date
    November 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED, THE CUSTOMER OBTAINED DISCREPANT BLOOD GLUCOSE VALUES OF HI (GREATER THAN 600 MG/DL) BACK TO BACK WITH A RESULT OF 158 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. REPORTER INDICATED, THE CUSTOMER WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. 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 549423

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR GLIPIZIDE - 5 YEARS - 5MG ONCE DAILY