BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3416157 · Received October 17, 2013

    Report

    Report Number
    2531779-2013-17920
    Event Type
    Malfunction
    Date Received
    October 17, 2013
    Report Date
    October 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/02/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THE KEYPAD WAS FULLY INTACT BUT THE KEYPAD WAS WORN. ALL OF THE BUTTONS RESPONDED APPROPRIATELY. EVALUATION REVEALED THERE WAS CONTAMINATION UNDER THE UP, DOWN AND CONTRACT KEY CONTACTS. UNRELATED TO THE CASE, THE DISPLAY LENS WAS SCRATCHED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER BUTTONS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/02/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534176 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR