BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2170909 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01866
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED WHEN SHE PRESSES THE MENU OR THE CHECK KEY BUTTON ON THE INFUSION DEVICE, THE DEVICE DOES NOT RESPOND. PATIENT STATED THIS IS THE FIRST TIME SHE HAS NOTICED THE ISSUES WITH THE BUTTONS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN| INSULIN INFUSION SET