BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3844446 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15538
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA REVEALED NO RECORDS OF POWER ON RESET AND NO ACTIVITY OUTSIDE NORMAL USE. ON INVESTIGATION, THE PUMP POWERED ON EVIDENCED BY FUNCTIONAL VIBRATION AND AUDITORY TONES. THE DISPLAY SCREEN REMAINED BLANK WHEN THE PUMP WAS POWERED ON. THE PUMP COVER WAS REMOVED FOR FURTHER INVESTIGATION, REVEALING A CRACKED DISPLAY SCREEN. THE DAMAGED DISPLAY WAS REMOVED AND REPLACED WITH A TEST DISPLAY, WHICH BECAME FULLY FUNCTIONAL WHEN ATTACHED. THE PUMP WAS NOT ABLE TO BE FULLY EXERCISED DUE TO THE DAMAGED DISPLAY SCREEN.

    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. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) 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
    321315 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR