BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3312018 · Received August 27, 2013

    Report

    Report Number
    2531779-2013-13923
    Event Type
    Malfunction
    Date Received
    August 27, 2013
    Report Date
    August 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/02/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE CONTRAST BUTTON WAS FOUND TO BE UNRESPONSIVE, WHICH HAS NO EFFECT ON INSULIN DELIVERY. THE KEYPAD COVER WAS REMOVED AND THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER CONTRAST KEY CONTACT. THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. THE DISPLAY WAS REPLACED WITH A TEST DISPLAY FOR INVESTIGATION AND WAS FOUND TO FUNCTION PROPERLY.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM, DISCOLORED DISPLAY SCREEN. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER THE CONTRAST BUTTON. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 08/02/2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420590 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR