BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1212603 · Received October 24, 2008

    Report

    Report Number
    1823260-2008-07872
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED DAUGHTER HAD SYMPTOMS OF HYPOGLYCEMIA, TESTED AND HAD AN ADVANTAGE SYSTEM BLOOD GLUCOSE RESULT OF 249 MG/DL. SHE WAS GIVEN JUICE AND EMT'S WERE CALLED. EMT'S SYSTEM RESULT WAS 46 MG/DL WITHIN 10 MINUTES OF THE CUSTOMER'S 249 MG/DL. THEY TREATED THE CUSTOMER WITH AN UNSPECIFIED IV AND TRANSPORTED HER TO A HOSP, WHERE 30 MINUTES LATER, HER BLOOD GLUCOSE WAS 77 MG/DL. CUSTOMER WAS RELEASED. A REQUEST WAS MADE FOR THE RETURN OF THE SYSTEM, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention NOVOLOG SLIDING SCALE| LEVEIMIR 32 UNITS/DAY