BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 3200923 · Received July 2, 2013

    Report

    Report Number
    2183996-2013-01203
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 26, 2013
    Report Date
    July 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 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 FUNCTIONS 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)(4) 2013, IT WAS REPORTED THAT THE UP AND DOWN BUTTONS ON THE PATIENT'S INFUSION DEVICE WERE 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. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301643 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 031 YR