BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1211350 · Received October 22, 2008

    Report

    Report Number
    1823260-2008-07780
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 517 MG/DL BACK TO BACK WITH A RESULT OF 198 MG/DL ON THE ADVANTAGE SYSTEM, WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER INDICATED THAT THE CUSTOMER TOOK 10 UNITS OF LANTUS INSULIN BASED ON THE 198 MG/DL RESULT. NO OTHER 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.

    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 550632

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR LANTUS - 8 YEARS - SLIDING SCALE| BLOOD PRESSURE MEDICATION