BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3533175 · Received December 23, 2013

    Report

    Report Number
    2531779-2013-24972
    Event Type
    Malfunction
    Date Received
    December 23, 2013
    Report Date
    December 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/12/2013 WITH THE FOLLOWING FINDINGS:DURING TESTING, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED. ADDITIONALLY, THE KEYPAD COVER WAS TORN FROM THE UP ARROW BUTTON TO THE CONTRAST BUTTON, AND THE CONTRAST BUTTON WAS UNRESPONSIVE, WHICH HAS NO EFFECT ON INSULIN DELIVERY. THE KEYPAD COVER WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE CONTRAST, UP ARROW, AND DOWN ARROW KEY CONTACTS. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY FAILURE AND CONTAMINATION UNDER THE KEYPAD BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/12/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673723 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR