BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1033988 · Received April 25, 2008

    Report

    Report Number
    1823260-2008-03571
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    April 18, 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
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S NIECE REPORTED AN INCIDENT OF HYPOGLYCEMIA REQUIRING PROFESSIONAL MEDICAL TREATMENT IN WHICH ADVANTAGE SYSTEM RESULT OF 163 MG/DL DID NOT MATCH SYMPTOMS. EMT METER RESULT AFTER 15 MINUTES WAS 39 MG/DL. CUSTOMER TREATED WITH IV. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE 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 550546

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LANTUS| NOVOLOG 20