BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760948 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06189
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 21, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT BLOOD GLUCOSE WAS TESTED, ON THE ADVANTAGE SYSTEM, WITH A RESULT OF 320 MG/DL. BASED ON THIS VALUE, PATIENT REPORTEDLY DELIVERED 12 UNITS NOVOLOG AND HAD LUNCH (PASTA WITH MEAT, VEGETABLES, AND FRUIT DRINK). PATIENT INDICATED THAT, FOUR HOURS LATER, A NEIGHBOR WAS UNABLE TO WAKE HIM. EMERGENCY MEDICAL SERVICES WERE SUMMONED AND, UPON THEIR ARRIVAL, PATIENT'S BLOOD GLUCOSE REPORTEDLY MEASURED 20 MG/DL ON PARAMEDICS' DEVICE. PATIENT INDICATED THAT HE WAS TREATED WITH AN [UNSPECIFIED] INJECTION AND GIVEN LIQUID TO DRINK. NO ADDITIONAL TREATMENT WAS RECEIVED. PATIENT REPORTEDLY FELT BETTER 30 MINUTES LATER. QUALITY CONTROL TESTING HAD NOT BEEN PERFORMED ON THE ADVANTAGE SYSTEM. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING SYSTEM - LFR LFR ROCHE DIAGNOSTICS 549702

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR NOVOLIN 45 UNITS - ONCE DAILY| NOVOLOG, SLIDING SCALE