BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2080774 · Received May 6, 2011

    Report

    Report Number
    2531779-2011-03207
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 9, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS PERFORMED DEVICE EVALUATION WITH THE PUMP INVOLVED WITH THIS COMPLAINT ON (B)(6) 2011. INVESTIGATION CONFIRMED THAT THE UP ARROW WAS INTERMITTENTLY ACTIVATING THE DESIRED PUMP FUNCTIONS. THERE WAS ALSO ADHESIVE (CONTAMINATION) FOUNDER UNDER THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UP ARROW WAS SLOW TO ACTIVATE THE DESIRED PUMP FUNCTIONS. ACCORDING TO THE PATIENT, THE PUMP HAS NOT BEEN EXPOSED TO MOISTURE AND THE KEYPAD APPEARS TO BE INTACT. THE REPORTED ISSUES WERE NOT RESOLVED WITH TROUBLESHOOTING WITH ANIMAS CUSTOMER SUPPORT. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR