BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172394 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01807
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 1, 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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT REPORTED HAVING INTERMITTENT ISSUES WITH THE DOWN BUTTON OF THE INFUSION DEVICE. THE BUTTON WORKED AT THE TIME OF THE REPORT. THE ISSUE BEGAN ABOUT A MONTH AGO WHILE ATTEMPTING TO BOLUS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED 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 23 YR INSULIN| INSULIN INFUSION SET