BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3812850 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13711
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/05/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE UP ARROW KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND THE UP ARROW KEY CONTACT WAS MISALIGNED. UNRELATED TO THIS ISSUE, THE BOLUS BUTTON COVER WAS MISSING FROM THE PUMP; EXPOSING THE KEY CONTACT. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A KEYPAD BUTTON RESPONSE ISSUE AND AN ISSUE WITH A KEY CONTACT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/05/2014. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291133 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1