BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1162092 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06911
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PHARMACIST REPORTED THE CUSTOMER HAD A BLOOD GLUCOSE RESULT OF 245 MG/DL ON THE ADVANTAGE SYSTEM AT A TIME WHEN HE WAS HAVING SYMPTOMS OF HYPOGLYCEMIA. PARAMEDICS HAD A 42 MG/DL WITHIN 10 MINUTES ON A PROFESSIONAL SYSTEM. CUSTOMER WAS GIVEN GLUCOSE GEL FOR SYMPTOMS OF HYPOGLYCEMIA. 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 549938

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention LANTUS 18 UNITS/DAY - 1 YEAR| HUMALOG SLIDING SCALE - 6-8 YEARS