BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 3234152 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11320
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANIMAS HAS REQUESTED THE SUBJECT PRODUCTS TO BE RETURNED FOR EVALUATION HOWEVER THE PRODUCTS HAVE NOT YET BEEN RETURNED OR EVALUATED. IF ANIMAS RECEIVES THE PRODUCT ANIMAS WILL INFORM THE FDA OF ANY PRODUCTS THAT FAIL EVALUATION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 09/10/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/20/2013 WITH THE FOLLOWING RESULTS: THERE'S NO VISIBLE DAMAGE TO THE KEYPAD. CANNOT TEST THE FUNCTIONALITY OF THE KEYPAD DUE TO MOISTURE INSIDE OF THE PUMP. REMOVED THE KEYPAD AND FOUND NO DAMAGE OR CONTAMINATION ON THE BUTTON CONTACTS. MOISTURE CAN BE SEEN FROM BEHIND THE DISPLAY LENS. PERFORMED THE LEAK TEST AND FOUND A LEAK DUE TO A CRACKED PUMP CASE. OPENED THE PUMP CASE AND FOUND MOISTURE THROUGHOUT THE PUMP CASE. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES W/MOISTURE) ISSUE. THE REPORTER ALLEGED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE REPORTER CONFIRMED MOISTURE UNDER THE SCREEN. 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
    335823 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR