BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3232516 · Received July 18, 2013

    Report

    Report Number
    2531779-2013-11146
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 10/14/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/26/2013 WITH THE FOLLOWING FINDINGS: THE CONTRAST, UP, AND DOWN BUTTONS WERE RESPONDING INTERMITTENTLY. THERE WAS NO DAMAGE TO THE KEYPAD. THE LEAK TEST FAILED DUE TO A CRACK IN THE PUMP AT THE RIGHT UPPER CORNER BETWEEN THE LENS AND THE CASE SEAL. THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND UNDER THE CONTRAST, UP, AND DOWN BUTTON CONTACTS. UNRELATED TO THE REPORTED ISSUE, CORROSION WAS FOUND ON THE FORCE SENSOR CIRCUITS, VIBRATOR MOTOR, THE BOTTOM OF THE CASE, AND BT1. MOISTURE WAS FOUND IN PUMP. 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, AFTER SWIMMING, THE KEYPAD BUTTONS WERE NOT RESPONDING APPROPRIATELY AND FELT LIKE THERE WAS MOISTURE BENEATH THEM. IT WAS ALSO NOTED THAT OK BUTTON WAS STICKING. 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
    334910 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR