BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULACCU-CHEK SPIRIT

    MDR report key: 2833392 · Received October 26, 2012

    Report

    Report Number
    2183996-2012-01647
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    August 27, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED THE RUBBER ON THE UP BUTTON OF THE INFUSION DEVICE IS COMPLETELY WORN OFF. PATIENT STATED THE BUTTONS ON THE INFUSION DEVICE ARE STILL FUNCTIONING PROPERLY. PATIENT REPORTED THE BASE PLATE MATERIAL SHOWS THROUGH. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 EVALUATION. THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN