BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6147153 · Received December 6, 2016

    Report

    Report Number
    2531779-2016-32943
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Report Date
    November 9, 2016
    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 11/09/2016 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED. UNRELATED TO THIS ISSUE, THE PUMP WAS RETURNED WITH THE KEYPAD PEELING OFF. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 11/09/2016. THE BATTERY COMPARTMENT WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798172 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1