BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2852085 · Received November 14, 2012

    Report

    Report Number
    2183996-2012-01722
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    August 6, 2012
    Report Date
    October 17, 2012
    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
    LH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THE UP BUTTON ON THE INFUSION DEVICE IS DEFECTIVE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND RETURNED FOR EVALUATION. THE EVALUATION REVEALED THE INFUSION DEVICE WAS DAMAGED DUE TO CARELESS HANDLING. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE MAY ENTER THE INFUSION DEVICE AND DESTROY THE FUNCTIONALITY OF THE BUTTONS AND THE ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES