BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2143258 · Received June 28, 2011

    Report

    Report Number
    1823260-2011-03500
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 19, 2011
    Report Date
    August 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CALLER STATES PATIENT RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WHILE USING COMFORT CURVE TEST STRIPS WITHIN 10 MINUTES: 425 MG/DL, 275 MG/DL, AND 167 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT 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 551349

    Patients

    Seq Age Sex Outcome Treatment
    1