BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3780933 · Received April 30, 2014

    Report

    Report Number
    2531779-2014-11757
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    April 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/15/2014 WITH THE FOLLOWING FINDINGS:THE KEYPAD COVER IS TORN OVER THE CONTRAST BUTTON. A DAMAGED KEYPAD WILL ALLOW CONTAMINATION TO PERMEATE THE BUTTON CONTACTS NEGATIVELY IMPACTING THE BUTTON FUNCTION. THE DAMAGED KEYPAD IS OBVIOUS AND DETECTABLE AND SHOULD ALERT THE USER TO DISCONTINUE USE OF THE PUMP. EVALUATION REVEALED THAT ALL OF THE KEYPAD BUTTONS RESPONDED APPROPRIATELY. EVALUATION REVEALED THAT THERE WAS CONTAMINATION UNDER ALL CONTACT BUTTONS. 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 THAT THERE WAS CONTAMINATION UNDER THE BUTTONS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 04/15/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259652 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR