BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2822014 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13227
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. SUBMITTED: (B)(4) 2012. DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE KEYPAD WAS FOUND TO BE FULLY INTACT WITHOUT PEELING OR VISIBLE DAMAGE. ON TESTING, ALL THE KEYPAD BUTTONS HAD NORMAL RESPONSE WITH NORMAL SPRING BACK AND CLICK. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE KEYPAD BUTTONS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING AN ISSUE WITH THE PUMP'S KEYPAD. THE PATIENT STATED THE OK BUTTON HAD INTERMITTENT UNRESPONSIVENESS THAT WAS NOTICED APPROXIMATELY FIVE WEEKS AGO. THE PATIENT REPORTEDLY WORE THE PUMP ATTACHED AT THE WAIST AND USED A LENS FILM FOR PROTECTION. THE PATIENT REPORTEDLY DOES NOT CLEAN THE PUMP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED KEYPAD MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR