BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1012307 · Received February 13, 2008

    Report

    Report Number
    1823260-2008-02402
    Event Type
    Injury
    Date Received
    February 13, 2008
    Date of Event
    March 9, 2008
    Report Date
    March 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY OBTAINED RESULTS OF 80MG/DL AND 88MG/DL ON THE VOICEMATE/ADVANTAGE SYS WHILE A PROFESSIONAL DEVICE PRODUCED A RESULT OF 50MG/DL WITHIN 10 MINS. CUSTOMER WAS TREATED WITH A GLUCOSE IV BY THE PARAMEDICS. REQUESTED RETURN OF SUSPECT SYS AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING DEVICE - LFR LFR ROCHE DIAGNOSTICS 550023

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention HUMALOG 4YRS 2-8UNITS/MEALS| LANTUS 4YRS 15UNITS/DAY| HUMALOG 4YRS PER CARBS