BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4110137 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27124
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 11/07/2014-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. THE KEYPAD COVER WAS UNDAMAGED. THE PUMP POWERED UP TO A BLANK DISPLAY SCREEN WITH AUDITORY AND VIBRATORY FEATURES. THE PUMP CASING WAS OPENED AND EVIDENCE OF MOISTURE INTRUSION WAS FOUND ON VARIOUS INTERNAL COMPONENTS. DUE TO THE BLANK SCREEN AND THE MOISTURE DAMAGES THE INVESTIGATION WAS UNABLE TO FULLY EVALUATE THE REPORTED BUTTON TACTILE ISSUE. NO CONCLUSION CAN BE DRAWN.

    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. (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THERE WAS TACTILE CHANGE TO THE KEYPAD. 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
    590770 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1