BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3811545 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13556
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN; THE DISPLAY WAS STILL READABLE. THE BATTERY CAP WAS NOT RETURNED. A NEW TEST CAP WAS USED FOR TESTING PURPOSES. UPON FURTHER EVALUATION OF THE PUMP; THE PUMP WAS EXERCISED FOR 24 HOURS. THE PUMP WAS POWERED ON AND DISPLAYED THE VERIFY SCREEN WITH THE VIBRATORY AND AUDIBLE FEATURES APPROPRIATELY FUNCTIONING. THE ¿EZPRIME¿ STEP WAS SUCCESSFULLY PERFORMED ON THE PUMP. THERE WERE NO ERRORS, ALARMS OR WARNINGS RELATED TO THE REPORTED COMPLAINT. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS FOUND TO BE USED OUTSIDE OF NORMAL USE/SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290218 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1