BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3233876 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11301
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 09/18/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT MOISTURE CAN BE SEEN FROM BEHIND THE DISPLAY LENS. PERFORMED THE LEAK TEST AND FOUND A DISPLAY LENS LEAK. OPENED THE PUMP CASE AND FOUND MOISTURE THROUGHOUT THE PUMP CASE INCLUDING ON THE KEYPAD FLEX CONNECTOR. THERE IS NO VISIBLE DAMAGE TO THE KEYPAD. THE UP, DOWN, AND OK BUTTONS ARE UNRESPONSIVE. THE CONTRAST BUTTON RESPONDS PROPERLY. REMOVED THE KEYPAD AND FOUND NO DAMAGE OR CONTAMINATION ON THE BUTTON CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335770 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR