BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 8317354 · Received February 7, 2019

    Report

    Report Number
    2531779-2019-01036
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Report Date
    February 5, 2019
    Manufacturer
    ANIMAS LLC
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05-FEB-2019 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS RETURNED WITHOUT THE KEYPAD WITHOUT THE RUBBER COVER. ALL KEYS WERE RESPONSIVE TO USER PRESSES. THE TAPE WAS REMOVED FROM THE KEYPAD AND THERE WAS CONTAMINATION FOUNDER UNDER ALL THE KEY CONTACTS. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. 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)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A BATTERY COMPARTMENT CRACK AND CONTAMINATION UNDER THE BUTTONS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05-FEB-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107030 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1