BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4792708 · Received May 22, 2015

    Report

    Report Number
    2531779-2015-17128
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Report Date
    May 8, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/19/2015 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS POWERED ON AND REVEALED THAT THE DISPLAY WAS DIM WITH DISCOLORED TEXT. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. ALSO UNRELATED TO THE DISPLAY ISSUE, THE CONTRAST BUTTON WAS FOUND TO BE INTERMITTENTLY UNRESPONSIVE, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. ALL OTHER BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD WAS REMOVED AND THERE WAS CONTAMINATION PRESENT UNDER ALL OF THE BUTTON CONTACTS.

    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) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE DISTRIBUTOR ALLEGED THAT THE DISPLAY SCREEN TEXT WAS DIM, FADED, AND DISCOLORED. 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
    335180 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1