BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3041322 · Received April 8, 2013

    Report

    Report Number
    2531779-2013-03794
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EXAMINED AND THE DISPLAY SCREEN WAS FOUND TO BE CROOKED; THE DISPLAY SCREEN WAS FOUND TO HAVE SHIFTED TO THE LEFT. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. PRODUCT ANALYSIS EVALUATED THE PUMP AND REVEALED THAT THE DISPLAY SCREEN WAS FOUND TO BE SHIFTED. THIS REPORT IS MADE BASED ON THE RESULTS OF EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143042 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR