BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2141033 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01624
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    September 19, 2010
    Report Date
    May 19, 2011
    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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE DOWN BUTTON ON THE INFUSION DEVICE DOES NOT FUNCTION PROPERLY. THIS CONCERN HAS BEEN ONGOING FOR 6-8 MONTHS. THE UP BUTTON CONTINUES TO FUNCTION AS INTENDED. PT HAS USED THIS INFUSION DEVICE FOR 1-2 YEARS AND BOLUSES 4-5 TIMES PER DAY. THE DOWN BUTTON DOES NOT POP UP AFTER IT IS PRESSED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL.

    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 42 YR INSULIN| INSULIN INFUSION SET