BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6245149 · Received January 12, 2017

    Report

    Report Number
    2531779-2017-01002
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Report Date
    December 20, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMITTED: 01/12/2017. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/20/2016 WITH THE FOLLOWING FINDINGS: DEVICE EVALUATION: ON INVESTIGATION, THE PUMP POWERED ON AND THE DISPLAY BECAME ILLUMINATED PER NORMAL OPERATION. THE DISPLAY SCREEN WAS DIM/FADED AND DISCOLORED.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DISPLAY ISSUE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/20/2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29158 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR