BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770683 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09401
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    October 8, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING A BLOOD GLUCOSE RESULT AT 5:00 PM OF 402 MG/DL ON HER ADVANTAGE SYSTEM AND SHE STATED FEELING "NORMAL"; HOWEVER, SHE ATE LESS FOOD DUE TO THE READING. REPORTER STATED TESTING BLOOD GLUCOSE AT 10:30 PM BECAUSE HER LEVEL WAS ELEVATED EARLIER AND SHE OBTAINED A GLUCOSE RESULT OF 400 MG/DL. AT THAT TIME, IT WAS STATED THE REPORTER'S RELATIVE DROVE HER TO THE EMERGENCY ROOM (ER). AT THE ER, IT WAS STATED REPORTER OBTAINED A BLOOD GLUCOSE RESULT OF 500 MG/DL ON HER SAME ADVANTAGE SYSTEM COMPARED TO THE NURSE'S MEASUREMENT OF 47, 54, AND 57 MG/DL THAT WAS PERFORMED WITHIN 5-10 MINUTES AFTERWARDS. REPORTER STATED SHE FELT HYPOGLYCEMIC SYMPTOMS AT THE TIME AND WAS PROVIDED ORANGE JUICE BY THE NURSE AT THE ER. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT WAS RECEIVED. 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 LFR ROCHE DIAGNOSTICS 549833

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR GLYBURIDE-METFORMIN 2-3YRS - 5-500MG 2 TABS TWICE| VERAPAMIL 15-20YRS - 240MG TWICE DAILY| TRICOR 1 YR - 45MG ONCE DAILY| HYDROCHLOROTHIAZIDE 15-20YRS - 25MG ONCE DAILY| LISINOPRIL 10 YRS - 40MG ONCE DAILY| PRAVASTATIN 1YR - 40MG ONCE DAILY| ACTOS - 45MG ONCE DAILY| DAILY