BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243406 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11766
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 15, 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: TESTING CONFIRMED INTERMITTENT RESPONSES TO BUTTON PRESSES ON THE 'UP','DOWN' AND 'CONTRAST' BUTTONS. THE 'OK' BUTTON RESPONDED TO TESTING. THERE WAS NO DAMAGE ON THE KEYPAD OBSERVED. THE KEYPAD COVER WAS REMOVED TO CHECK CONDITION OF THE BUTTON CONTACTS AND CONTAMINATION WAS OBSERVED UNDER THE CONTACTS OF ALL BUTTONS. UNRELATED TO THE INITIAL COMPLAINT, THE TEXT ON THE DISPLAY SCREEN WAS DIM AND DISCOLORED. THE DIM DISPLAY WAS REMOVED AND REPLACED WITH A TEST DISPLAY AND FOUND TO BE FULLY FUNCTIONAL WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION OF TEXT. 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/UNRESPONSIVE) ISSUE. THE REPORTER ALLEGED THAT THE DOWN ARROW BUTTON WAS INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. 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
    343282 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR