BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083896 · Received July 28, 2008

    Report

    Report Number
    1823260-2008-05827
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 28, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE CUSTOMER OBTAINED A DISCREPANT BLOOD GLUCOSE RESULT OF 419 MG/LDL ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 62 OR 68 MG/DL ON THE LAB SYSTEM WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO ACTIONS WERE REPORTEDLY 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 NBW ROCHE DIAGNOSTICS 549832

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HUMALOG - 30 YEARS - 30 UNITS DAILY| LANTUS - 5 YEARS - 20 UNITS DAILY