BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5254922 · Received November 30, 2015

    Report

    Report Number
    2531779-2015-43203
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Report Date
    November 6, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    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 11/06/2015 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. UNRELATED TO THESE ISSUES, THE KEYPAD COVER WAS PEELING AT THE OK BUTTON. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE AND DAMAGE TO THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/06/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784090 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1