BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770838 · Received November 12, 2007

    Report

    Report Number
    1823260-2007-09842
    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 STATED, A COMPARATIVE TEST OF HI (GREATER THAN 600 MG/DL) WAS PERFORMED BACK TO BACK WITH A RESULT OF 142 MG/DL 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. THE REPORTER STATED, THE CUSTOMER NO LONGER HAS THE ALLEGED PRODUCT AND SO IT WILL NOT BE RETURNED FOR EVALUATION.

    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 UNK

    Patients

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