BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3961476 · Received July 28, 2014

    Report

    Report Number
    2531779-2014-21589
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/14/2014 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND NO COSMETIC DAMAGES. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. THE VERIFY SCREEN WAS BLANK AND THE DISPLAY WAS FOUND TO BE CRACKED. DUE TO THE BLANK DISPLAY, THE REMAINING TESTING WAS NOT COMPLETED AND THE REPORTED SEGMENT MISSING ISSUE WAS NOT FULLY INVESTIGATED. NO CONCLUSION CAN BE DRAWN. PUMP CASING WAS OPENED AND THE DAMAGED DISPLAY WAS REPLACED WITH A TEST DISPLAY. THE TEST DISPLAY WAS FULLY FUNCTIONAL AND READABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING A DISPLAY (SEGMENTS MISSING) ISSUE. 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
    437831 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1