BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 5071631 · Received September 11, 2015

    Report

    Report Number
    2531779-2015-32560
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    September 9, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/09/2015 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THE KEYPAD WAS PEELING. THE CONTRAST BUTTON WAS UNRESPONSIVE AND THE UP ARROW KEYPAD BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED AND THERE WAS EVIDENCE OF CONTAMINATION UNDER THE UP ARROW BUTTON CONTACT. ADDITIONALLY, THE CONTRAST BUTTON CONTACT WAS MISSING. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THERE WAS CONTAMINATION UNDER THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/09/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603424 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24