BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 5844561 · Received August 3, 2016

    Report

    Report Number
    2531779-2016-18736
    Event Type
    Malfunction
    Date Received
    August 3, 2016
    Report Date
    July 13, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    MDS
    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 7/13/2016 WITH THE FOLLOWING FINDINGS: DURING TESTING, IT WAS OBSERVED THAT THE BATTERY COMPARTMENT WAS CRACKED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 7/13/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497594 ANIMAS VIBE INSULIN INFUSION PUMP MDS ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1