BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 3012060 · Received March 20, 2013

    Report

    Report Number
    2183996-2013-00441
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ROCHE DIABETES CARE AG
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE, MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE BUTTONS FUNCTION WERE TESTED SUCCESSFUL AND MEET THE SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE UP AND DOWN BUTTONS ON THE PATIENT'S INFUSION DEVICE WERE DAMAGED AND NOT FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116850 ACCU-CHEK SPIRIT INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1