BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1555973 · Received November 30, 2009

    Report

    Report Number
    1823260-2009-08118
    Event Type
    Malfunction
    Date Received
    November 30, 2009
    Date of Event
    November 12, 2009
    Report Date
    November 30, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES PT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM AFTER BEING TREATED WITH MILK AND YOGURT: 28 MG/DL (0139), 49 MG/DL (0148_.22 MG/DL(0158), 114 MG/DL (0200), 47 MG/DL (0203), 74 MG/DL (0205), 15 MG/DL (0211), 15 MG/DL (0215), 23 MG/DL (0220), 28 MG/DL (0227), 41 MG/DL (0231), 50 MG/DL (0235), AND 51 MG/DL (0239). LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. PT WAS ALSO TREATED WITH AN INJECTION OF GLUCAGON WHEN RESULT OF 15 MG/DL WAS OBTAINED. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT 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 551073

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR LISINOPRIL| CITALOPRAM| VENTILATOR| ALBUTEROL INHALER| CARVEDILOL| ARICEPT| FINASTERIDE| INSULIN HUMAN NPH| MILK OF MAGNESIA| TYLENOL| WARFARIN| TUBERSOL| THIAMINE| QUETIAPINE| NICOTINE GUM