BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4820240 · Received June 4, 2015

    Report

    Report Number
    2531779-2015-18631
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Report Date
    May 21, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/21/2015 WITH THE FOLLOWING FINDINGS: THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. THE KEYPAD WAS DAMAGED BUT ALL OF THE KEYPAD BUTTONS WERE STILL RESPONSIVE. CONTAMINATION WAS FOUND UNDERNEATH THE CONTRAST BUTTON CONTACT. (B)(6)

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 05/21/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362140 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR