BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2133082 · Received June 18, 2011

    Report

    Report Number
    2531779-2011-04267
    Event Type
    Malfunction
    Date Received
    June 18, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. EVALUATION FOUND THAT THE RUBBER KEYPAD WAS WORN BUT NOT PEELING OR TORN. DURING TESTING, THE DOWN ARROW KEYPAD BUTTON WAS FOUND TO BE INTERMITTENTLY RESPONSIVE TO USER BUTTON PRESSES. ALL OTHER BUTTONS WERE FOUND TO BE FULLY FUNCTIONAL. THE DOWN ARROW KEY CONTACT WAS OBSERVED TO BE INVERTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KEYPAD BUTTONS REQUIRE MULTIPLE PRESSES TO ELICIT THE INTENDED RESPONSE. THERE WAS NO REPORT OF PROGRAMMING ERRORS AS A RESULT OF THE ISSUE

    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