BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3251520 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-11995
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: DURING EVALUATION, THE PUMP WAS POWERED ON AND THE DISPLAY SCREEN WAS FOUND TO BE DIM. A TEST SCREEN WAS INSTALLED AND DISPLAYED NORMALLY. UNRELATED TO THE DISPLAY ISSUE, THE KEYPAD COVER WAS COMPLETELY PEELED OFF AND THE CONTRAST BUTTON WAS MISSING. THE CONTRAST BUTTON WAS INOPERABLE; ALL OTHER BUTTONS RESPONDED APPROPRIATELY. EVIDENCE OF CONTAMINATION WAS FOUND UNDER THE UP ARROW, DOWN ARROW, AND OK KEY CONTACTS.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A DIM DISPLAY SCREEN. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352495 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR