BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6933574 · Received October 9, 2017

    Report

    Report Number
    2531779-2017-23294
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Report Date
    September 15, 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 09/15/2017 WITH THE FOLLOWING FINDINGS: THE BOTTOM OF THE DISPLAY WAS CRACKED. INITIAL REPORTER: ANIMAS CORPORATION (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THE DISPLAY WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/15/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708113 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1