BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2191953 · Received August 4, 2011

    Report

    Report Number
    1823260-2011-04198
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 14, 2011
    Report Date
    September 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED RESULTS OF 267 MG/DL AND 105 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. CUSTOMER WAS GIVEN FOOD BY HIS CAREGIVER. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE 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 TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551448

    Patients

    Seq Age Sex Outcome Treatment
    1 058 YR NOVOLIN 70/30