BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2833372 · Received October 26, 2012

    Report

    Report Number
    2183996-2012-01661
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 23, 2012
    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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PT'S DAUGHTER REPORTED THE CHECK BUTTON ON THE INFUSION DEVICE IS NOT WORKING CORRECTLY. DAUGHTER STATED ALL OF THE BUTTONS ARE WORKING EXCEPT FOR THE CHECK BUTTON. DAUGHTER REPORTED THE UP AND DOWN BUTTONS ON THE INFUSION DEVICE IS RESPONSIVE. DAUGHTER STATED HER MOTHER HAS TO PRESS THE CHECK BUTTON HARD TO GET IT TO WORK. DAUGHTER REPORTED THE BUTTON FAILURE IS INTERMITTENT AND BEGAN ABOUT A MONTH AGO. DAUGHTER STATED THE BUTTON IS FLAT AND THE INFUSION DEVICE DID MAKE AN AUDIBLE SOUND WHEN THE BUTTON WAS PRESSED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR INSULIN INFUSION PUMP| ACCESSORIES| INSULIN