BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4113488 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27285
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 12, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD IS CUT AND TORN BETWEEN THE DOWN AND OK BUTTONS. 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 THE UP AND DOWN KEYS ARE INTERMITTENTLY UNRESPONSIVE AND THE OK AND CONTRAST KEYS RESPOND APPROPRIATELY. EVALUATION REVEALED THAT THERE WAS CONTAMINATION UNDER ALL BUTTONS. THE DISPLAY WAS FOUND TO BE DIM AND PINK.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THERE WAS CONTAMINATION UNDER THE BUTTONS AND THE DISPLAY WAS DINK AND PINK. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593219 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR