BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3558224 · Received January 7, 2014

    Report

    Report Number
    2531779-2014-00594
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Report Date
    December 23, 2013
    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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/23/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED A DISCOLORED AND DIM DISPLAY SCREEN. INVESTIGATION ALSO REVEALED A CONTAMINATION FOUND UNDER THE BUTTON KEY CONTACTS. THE KEYPAD BUTTONS WERE FOUND TO BE RESPONSIVE TO USER INPUT. 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)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISCOLORED AND DIM DISPLAY SCREEN. INVESTIGATION REVEALED ALSO REVEALED CONTAMINATION FOUND UNDER THE BUTTON KEY CONTACTS. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/23/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9992 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1