BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2150258 · Received June 10, 2011

    Report

    Report Number
    2183996-2011-01653
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    November 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
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE UP BUTTON ON THE INFUSION DEVICE IS NO LONGER RESPONDING TO PRESSES PROPERLY. PT STATED, THE BUTTON IS ERRATIC IN RESPONDING. PT STATED, SHE FIRST NOTICED THE ISSUE ABOUT 6 MONTHS AGO WHILE ATTEMPTING TO INCREASE A BOLUS. PT REPORTED, THE BUTTON POPS OUT WHEN PRESSED AND RELEASED. PT STATED, THE BUTTON SOMETIMES WORK AND SOMETIMES IT DOESN'T. 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 PRODUCT 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 38 YR INSULIN| INSULIN INFUSION SET