BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1011474 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02303
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 1, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S SON REPORTS CUSTOMER RECEIVED HIGH BLOOD GLUCOSE RESULT OF 235MG/DL WITH LOW BLOOD GLUCOSE SYMPTOMS WHILE USING THE ADVANTAGE SYSTEM. SON REPORTS CUSTOMER PASSED OUT A COUPLE OF MINUTES LATER. SON REPORTS HE TREATED CUSTOMER WITH ORANGE JUICE. SON REPORTS CUSTOMER TESTED USING A DIFFERENT CONSUMER METER WITH A RESULT OF 43MG/DL. SON STATES HE TOOK CUSTOMER TO THE ER; WAS GIVEN ORANGE JUICE AND ADMITTED TO STAY OVERNIGHT. SON DOES NOT KNOW READINGS OR TREATMENT RECEIVED AT THE HOSPITAL. NO CONTROLS WERE RUN DURING THE EVENT. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention NOVOLIN SLIDING SCALE 2X/DAY