BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3924504 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19468
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 19, 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 06/19/2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS TORN OVER THE DOWN ARROW BUTTON. THE CONTRAST BUTTON WAS INTERMITTENTLY UNRESPONSIVE. CONTAMINATION WAS FOUND UNDERNEATH THE UP AND CONTRAST BUTTON CONTACTS. THE PUMP BOOTED UP TO A DIM AND DISCOLORED DISPLAY SCREEN. 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 UNRESPONSIVE KEYPAD BUTTONS WITH CONTAMINATION ON THE KEYPAD CONTACTS IN ADDITION TO DAMAGE TO THE KEYPAD AND A DIM AND DISCOLORED DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 06/19/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402083 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1