BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3380224 · Received October 1, 2013

    Report

    Report Number
    2531779-2013-16467
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Report Date
    September 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/09/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED THAT THERE WAS CONTAMINATION FOUND UNDER THE KEY CONTACTS. THE KEYPAD WAS FOUND TO BE INTACT AND THE CONTRAST BUTTON WAS FOUND TO BE UNRESPONSIVE. THE CONTRAST BUTTON HAS NO AFFECT ON INSULIN DELIVERY FUNCTION. THE REMAINING 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.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THERE WAS CONTAMINATION FOUND UNDER THE KEY CONTACTS. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/09/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495946 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR