BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4110970 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27140
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS OBSERVED TO BE PEELING, WORN AND THINNING. THE UP AND DOWN BUTTONS WERE INTERMITTENTLY UNRESPONSIVE TO TESTING. THE DISPLAY WAS OBSERVED TO BE DIM, FADING, AND REDDISH IN COLOR. THE BOLUS BUTTON COVER WAS OBSERVED TO BE DETACHED. THE KEYPAD COVER WAS REMOVED FOR FURTHER INVESTIGATION AND CONTAMINATION WAS FOUND UNDER ALL CONTACTS.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM, RED DISPLAY, INTERMITTENT FUNCTION TO THE UP AND DOWN BUTTONS AND CONTAMINATION ON ALL OF THE BUTTON CONTACTS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591376 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR