BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1033985 · Received April 25, 2008

    Report

    Report Number
    1823260-2008-03558
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATES THAT THE CUSTOMER EXPERIENCED AN EVENT WHERE SHE SEMICONSCIOUS WITH A BLOOD GLUCOSE RESULT OF 92MG/DL ON THE ACCU-CHEK ADVANTAGE SYSTEM. THE CUSTOMER'S BLOOD GLUCOSE WAS 20MG/DL ON THE PROFESSIONAL METER. SHE RECEIVED THIRD PARTY INTERVENTION. THE CUSTOMER'S NORMAL BLOOD GLUCOSE RANGE NOT PROVIDED. 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 550519

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention HUMALOG SLIDING SCALE| LEVEMIR