BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4146231 · Received October 6, 2014

    Report

    Report Number
    2531779-2014-28407
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/24/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE LABEL WAS TORN. THE DISPLAY HAD A PINK CONTRAST. A DISPLAY LENS LEAK WAS FOUND DURING LEAK TEST. MOISTURE WAS SEEN ON THE DISPLAY AND INSIDE THE PUMP BUT NOT IN THE BATTERY COMPARTMENT. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THAT THE DISPLAY HAD A PINK CONTRAST. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 09/24/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624519 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR