BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1870469 · Received October 6, 2010

    Report

    Report Number
    2183996-2010-02068
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 1, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE WAS DEFECTIVE. THIS WAS NOTICED WHEN PT ATTEMPTED TO BOLUS ONE WEEK PRIOR TO REPORT. DOWN BUTTON HAS CONTINUED TO WORK INTERMITTENTLY BUT IS GETTING WORSE. UP BUTTON CONTINUES TO FUNCTION AS INTENDED. PT HAS USED THIS INFUSION DEVICE SINCE (B)(6) 2008, AND BOLUSES APPROX 4 TIMES PER DAY. DOWN BUTTON POPS UP AFTER IT IS PRESSED. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 48 YR INSULIN| INSULIN INFUSION SET