BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3961792 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21604
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 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 OBSERVED TO BE CRACKED AT THE OPENING OF THE BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL THE O-RING WAS SEATED AND THE CAP WAS FLUSH WITH THE PUMP CASE. THERE WAS NO ISSUE WITH LOSS OF POWER DURING TESTING AND NO EVIDENCE OF MOISTURE DAMAGE IN THE BATTERY COMPARTMENT. THE TEXT ON THE DISPLAY SCREEN WAS OBSERVED TO BE DIM, FADED AND DISCOLORED AT THE HIGHEST CONTRAST SETTING. 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 A CRACKED BATTERY COMPARTMENT AND A DIM, FADED AND DISCOLORED DISPLAY SCREEN. 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
    439718 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1