BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4915428 · Received July 15, 2015

    Report

    Report Number
    2531779-2015-23805
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Report Date
    June 29, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/17/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/27/2015 WITH THE FOLLOWING FINDINGS: THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED. THE KEYPAD COVER WAS INTACT WITH NO VISIBLE DAMAGE OBSERVED. ALL THE KEYPAD BUTTONS RESPONDED NORMALLY. THE KEYPAD COVER WAS REMOVED AND THERE WAS NO CONTAMINATION FOUNDER UNDER THE BUTTON CONTACTS. UNRELATED TO THE ORIGINAL COMPLAINT, THE BOLUS BUTTON COVER WAS TORN BUT RESPONDED APPROPRIATELY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE OK KEYPAD BUTTON WAS UNDER-RESPONSIVE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458601 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR