BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3850857 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-15884
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/29/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM, FADED AND DISCOLORED. THE CONTRAST SETTING WAS INCREASED TO THE MAXIMUM OF '10' WITH LITTLE IMPROVEMENT OBSERVED. EVALUATION ALSO REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AT OPENING OF BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. UNRELATED TO THESE ISSUES, THE PUMP CASE WAS FOUND TO BE DAMAGED WHERE THE LOW PROFILE CLIP ATTACHES TO THE PUMP, WHICH DOES NOT AFFECT THE INSULIN DELIVERY FUNCTION OF THE PUMP. A TEST CLIP WAS ATTACHED TO PUMP AND WOULD NOT STAY IN PLACE. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM, FADED AND AND DISCOLORED. EVALUATION ALSO REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/29/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330186 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1