BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3843817 · Received June 2, 2014

    Report

    Report Number
    2531779-2014-15468
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 05/28/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. THE DISPLAY SCREEN WAS ALSO SCRATCHED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY FAILURE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/28/2014. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321533 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR