BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4161962 · Received October 10, 2014

    Report

    Report Number
    2531779-2014-28874
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/30/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. THE KEYPAD COVER WAS PEELING. ALL THE BUTTONS RESPONDED INTERMITTENTLY AND REMOVAL OF THE KEYPAD COVER FOUND CONTAMINATION UNDER ALL THE BUTTON CONTACTS. THE REPORTED KEYPAD ISSUE WAS DUPLICATED IN THE INVESTIGATION. UNRELATED TO THE KEYPAD ISSUE, THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED FROM THE TOP TO THE GRIP PAD. IN ADDITION, THE DISPLAY WAS DIM AND DISCOLORED.

    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)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT THE ¿UP¿, ¿DOWN¿ AND ¿OK¿ BUTTONS WERE UNDER RESPONSIVE PRIOR TO THE COVER BEING DAMAGED. 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
    644239 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1