BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT INSULIN

    MDR report key: 3192302 · Received June 27, 2013

    Report

    Report Number
    2183996-2013-01178
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 16, 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 SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY. THEREFORE MOISTURE MAY ENTER THE INSULIN PUMP AND DESTROY THE PUMP ELECTRONICS. THE BUTTONS WERE TESTED SUCCESSFULLY AND COMPLY WITH THE PRODUCT SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    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.

    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 NOT FUNCTIONING. THE PATIENT REPORTED THAT THE RUBBER COVERING OF THE BUTTONS BEGAN TO DETERIORATE ABOUT A YEAR AGO, BUT THEY HAVE JUST NOW STOPPED FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294395 ACCU-CHEK SPIRIT INSULIN INSULIN INFUSION DEVICE LZG ROCHE DIABETES CARE AG 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 019 YR