BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3516461 · Received December 12, 2013

    Report

    Report Number
    2531779-2013-23918
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Report Date
    December 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/02/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. THE KEYPAD COVER HAD BEEN RETURNED TORN. THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. ADDITIONALLY, THE THREADS OF THE BATTERY CAP WERE FOUND TO BE STRIPPED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED CONTAMINATION UNDER KEY CONTACTS, A DISPLAY SCREEN FAILURE, AND BATTERY CAP DAMAGE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 12/02/2013. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652199 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR