BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4132920 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28028
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS CRACKED. THE BATTERY CAP WAS NOT RETURNED WITH THE DEVICE, SO A TEST BATTERY CAP WAS USED AND WAS ABLE TO FULLY TIGHTEN TO THE PUMP AND THERE WERE NO ISSUES WITH LOSS OF POWER. THERE WAS NO EVIDENCE OF MOISTURE DAMAGE INSIDE THE BATTERY COMPARTMENT. THE BUMPER BAD ON THE PUMP WAS DETACHED AND MISSING. 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. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT BATTERY COMPARTMENT WAS CRACKED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613279 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1