BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2971664 · Received January 30, 2013

    Report

    Report Number
    2183996-2013-00134
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 25, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE MOISTURE ENTERED THE INSULIN PUMP AND DESTROYS THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON DOES NOT RESPOND TO COMMANDS DUE TO THE CONTAMINATION INSIDE THE BUTTON. 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 ONLY FUNCTIONING INTERMITTENTLY AND THE RUBBER COVERING THE BUTTONS APPEARED TO BE WORN OUT. 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
    41975 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP