BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760865 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06048
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED, CUSTOMER OBTAINED DISCREPANT BLOOD GLUCOSE VALUES OF 311 MG/DL ON CUSTOMER'S ADVANTAGE SYSTEM COMPARED TO A RESULT OF 111 MG/DL ON THE NURSES STATION SYSTEM WHEN TESTING WAS PERFORMED WITHIN 5 MINUTES. REPORTER STATED, THE COMPARISON WAS PERFORMED WITHIN 10-15 MINUTES AFTER A BACK TO BACK COMPARISON OF 362 MG/DL VERSUS 411 MG/DL WAS PERFORMED ON THE CUSTOMER'S SAME ADVANTAGE SYSTEM. NO ACTIONS WERE TAKEN OR TREATMENT 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 549207

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR