BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6665780 · Received June 23, 2017

    Report

    Report Number
    2531779-2017-13236
    Event Type
    Malfunction
    Date Received
    June 23, 2017
    Report Date
    June 2, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    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 06/02/2017 WITH THE FOLLOWING FINDINGS: MOISTURE WAS FOUND IN THE BATTERY COMPARTMENT. A LEAK TEST WAS PERFORMED AND FAILED DUE TO A LEAK IN THE BATTERY COMPARTMENT. THE BATTERY COMPARTMENT WAS CRACKED ABOVE THE BUMPER AT THE THREADS. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/02/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445973 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1