BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083313 · Received July 25, 2008

    Report

    Report Number
    1823260-2008-05793
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED DISCREPANT BLOOD GLUCOSE RESULTS OF 25 MG/DL, 134 MG/DL, 310 MG/DL AND 52 MG/DL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 123 MG/DL ON A PROFESSIONAL SYSTEM WHEN TESTING WAS PERFORMED WITHIN TEN MINUTES. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. 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 550670

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR ORAL DIABETIC MEDICATION