BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3519341 · Received December 13, 2013

    Report

    Report Number
    2531779-2013-24179
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Report Date
    December 2, 2013
    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 12/02/2013 WITH THE FOLLOWING FINDINGS:VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED FROM THE FINGER PAD DOWN TO THE PRIMARY SEAL. THERE WAS NO EVIDENCE OF ANY POWER ISSUES. UNRELATED TO THE BATTERY COMPARTMENT DAMAGE, INVESTIGATION REVEALED THAT THE KEYPAD COVER WAS TORN AND LIFTING, EXPOSING THE BUTTON CONTACTS. ALL KEYPAD BUTTONS RESPONDED NORMALLY TO BUTTON PRESSES. 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)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A CRACK IN THE BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/02/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653854 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1