BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5856292 · Received August 9, 2016

    Report

    Report Number
    2531779-2016-19589
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Report Date
    August 8, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/08/2016 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY WAS DIM AND DISCOLORED. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. (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 08/08/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515873 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1