BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6041551 · Received October 19, 2016

    Report

    Report Number
    2531779-2016-29116
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Report Date
    October 2, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100051
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/14/2016 ¿ DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/18/2016 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE KEYPAD BUTTONS RESPONDED APPROPRIATELY TO USER INPUT. NO PHYSICAL DAMAGE WAS FOUND TO THE KEYPAD. THE KEYPAD WAS REMOVED TO FIND NO CONTAMINATION OR PHYSICAL DAMAGE. THE ORIGINAL COMPLAINT OF UNDER RESPONSIVE KEYPAD BUTTONS COULD NOT BE DUPLICATED. UNRELATED TO THE ORIGINAL COMPLAINT, THE AUDIO BOLUS BUTTON COVER WAS TORN BUT STILL OPERABLE. ADDITIONALLY, THE BATTERY COMPARTMENT WAS CRACKED FROM THE CASE SEAL TO THE GRIP PAD. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED THAT THE UP AND DOWN ARROW KEYS AND THE OKAY KEY WERE UNRESPONSIVE. THERE WAS NO INDICATION THAT THE ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE HAS THE ABILITY TO RESULT IN INADVERTENT OR INCORRECT INSULIN DELIVERY OR THE INABILITY TO USE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691792 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100051

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR