BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3933968 · Received July 15, 2014

    Report

    Report Number
    2531779-2014-20019
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/18/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE INTACT; NO PEELING OR LIFTING WAS OBSERVED. EVALUATION REVEALED THAT ALL KEYPAD BUTTONS RESPONDED APPROPRIATELY TO BUTTON PRESSES. THERE WAS EVIDENCE OF KEYPAD CONTAMINATION FOUND UNDER ALL THE CONTRAST BUTTON CONTACT. THE BOLUS BUTTON COVER WAS FOUND TO BE TORN AND THE BOLUS BUTTON WAS UNRESPONSIVE. INVESTIGATION FOUND THAT THE BOLUS BUTTON ¿SLUG¿ WAS MISSING. ADDITIONALLY, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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 BOLUS BUTTON RESPONSE ISSUE, CONTAMINATION UNDER THE BUTTON CONTACTS, AND A DIM DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/18/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412525 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1