BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6668983 · Received June 26, 2017

    Report

    Report Number
    2531779-2017-13309
    Event Type
    Malfunction
    Date Received
    June 26, 2017
    Report Date
    June 2, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/02/2017 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED BELOW THE GRIP PAD. A TEST BATTERY CAP WAS ABLE TO FIT. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY ALARMS TO A BLANK DISPLAY. THE PUMP COVER WAS REMOVED TO FIND A CRACKED EEPROM INTERNAL COMPONENT. AN EEPROM FAILURE WAS CONCLUDED. (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 06/02/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447068 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1