BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK COMFORT CURVE TEST STRIPS

    MDR report key: 1232145 · Received November 14, 2008

    Report

    Report Number
    1823260-2008-08424
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    September 3, 2008
    Report Date
    November 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ADVANTAGE SYSTEM BLOOD GLUCOSE RESULT OF 294 MG/DL AT A TIME WHEN SHE WAS SYMPTOMATIC OF HYPOGLYCEMIA, EMT HAD A RESULT OF 31 MG/DL WITHIN 10 MINUTES ON A PROFESSIONAL SYSTEM. CUSTOMER REPORTED TREATMENT WITH IV DEXTROSE. 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-CHECK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R GLIPIZIDE: 40 MG/DAY| LANTUS: 50 UNITS/DAY