BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 7293090 · Received February 23, 2018

    Report

    Report Number
    2531779-2018-04115
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Report Date
    February 20, 2018
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100242
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 20-FEB-2018 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED ABOVE THE GRIP PAD. ANIMAS CORPORATION (B)(4).

    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 20-FEB-2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136116 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100242

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR