BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6255174 · Received January 16, 2017

    Report

    Report Number
    2531779-2017-01286
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Report Date
    December 20, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE, BATTERY COMPARTMENT DAMAGE AND MOISTURE INGRESS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/20/2016. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/20/2016 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: ON INVESTIGATION, THE PUMP POWERED ON AND THE DISPLAY BECAME ILLUMINATED PER NORMAL OPERATION. THE DISPLAY SCREEN WAS EXAMINED AND FOUND TO BE DIM/FADED AND DISCOLORED. THE BATTERY COMPARTMENT WAS CRACKED AND THE PUMP EXPERIENCED MOISTURE INGRESS.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/20/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37974 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1