BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7581163 · Received June 8, 2018

    Report

    Report Number
    2531779-2018-10565
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/01/2018 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED BELOW AND ABOVE THE GRIP PAD. (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 06/01/2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427338 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR