BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1071244 · Received July 9, 2008

    Report

    Report Number
    1823260-2008-05301
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 21, 2008
    Report Date
    July 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CALLER STATES THAT THE CUSTOMER EXPERIENCED AN EVENT WHERE HE WAS UNRESPONSIVE WITH A BG RESULT IN THE 380'S (MG/DL) ON THE ACCU-CHEK ADVANTAGE SYSTEM. WITHIN 30 MINUTES THE CUSTOMER'S BG WAS 42 MG/DL ON THE PROFESSIONAL METER. HE RECEIVED GLUCOSE INTRAVENOUSLY. THE CUSTOMER RECEIVED INSULIN 3 HOURS AND 45 MINUTES PRIOR TO EVENT BASED ON ACCU-CHEK ADVANTAGE SYSTEM RESULT OF 345 MG/DL. THE CALLER DID NOT REALIZE THAT THE STRIPS USED DURING THE EVENT WERE EXPIRED UNTIL AFTER THE EVENT. NEW SYSTEM SENT AND RETURN REQUESTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention ISOSORBIDE 30MG/DAY - 1 WEEK| LISINOPRIL 5MG/DAY - 1 WEEK| HUMALOG SLIDING SCALE| LANTUS 15 UNITS/DAY