BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2081622 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-01006
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 4, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED, THE UP BUTTON OF THE INFUSION DEVICE IS DEFECTIVE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL. UPON EVAL OF THE INFUSION DEVICE, IT WAS FOUND THE UP/DOWN BUTTON IS ALWAYS ACTIVE. DUE TO AN EXTERNAL MECHANICAL INFLUENCE, THE SNAP DOME OF THE UP/DOWN BUTTON IS PRESSED THROUGH. THIS SOURCE LED TO AN ALWAYS ACTIVATED UP/DOWN BUTTON AND, THEREFORE, ALL THE BUTTONS DO NOT REACT ON PRESSURE. THE ISSUE IS RELATED TO USER HANDLING.

    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 INSULIN INFUSION SET| INSULIN