BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8685550 · Received June 10, 2019

    Report

    Report Number
    2531779-2019-03522
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Report Date
    June 7, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09-AUG-2019 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR DAMAGE WAS OBSERVED. ALL OF THE KEYPAD BUTTONS WERE RESPONSIVE DURING TESTING. THE KEYPAD WAS REMOVED AND NO EVIDENCE OF CONTAMINATION OR DAMAGE WAS FOUND ON THE BUTTON CONTACTS. THE COMPLAINT OF A KEYPAD BUTTON RESPONSE ISSUE WAS NOT DUPLICATED DURING INVESTIGATION. LEAK TESTING REVEALED A LEAK DUE TO THE CRACKED PUMP CASE. THE PUMP WAS OPENED AND THERE WAS EVIDENCE OF MOISTURE CORROSION ON THE KEYPAD CONNECTOR, DISPLAY BOARD, AND TRANSCEIVER BOARD. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A DIM, DISCOLORED DISPLAY. 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. IT WAS REPORTED THAT ALL OF THE KEYPAD BUTTONS WERE UNDER RESPONSIVE AND THERE WAS MOISTURE IN THE CARTRIDGE COMPARTMENT. THERE WAS NO INDICATION THAT THE PRODUCT 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
    477339 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR