BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3420944 · Received October 21, 2013

    Report

    Report Number
    2531779-2013-18275
    Event Type
    Malfunction
    Date Received
    October 21, 2013
    Report Date
    October 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/09/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED KEYPAD PEELING FROM BOTTOM THROUGH "CONTRAST" KEY. 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. THE CONTRAST KEY IS NOT RESPONDING. THE UP, DOWN AND OK KEYS RESPONDED APPROPRIATELY. THE KEYPAD FLEX CABLE WAS DAMAGED AT CONTRAST KEY. THERE WAS GREEN MOISTURE CONTAMINATION UNDER ALL KEY CONTACTS. THERE WERE BATTERY COMPARTMENT CRACKS OBSERVED IN THREAD AREA AND BELOW GRIP PAD. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION INSIDE BATTERY COMPARTMENT. LEAK TEST SHOWED LEAK AT CRACKS IN BATTERY COMPARTMENT. (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 10/09/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539527 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR