BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3143171 · Received June 3, 2013

    Report

    Report Number
    2531779-2013-07515
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 07/25/2013DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD WAS INTACT WITHOUT DAMAGE. ON TESTING, ALL THE BUTTONS HAD INTERMITTENT RESPONSE. THE REMAINDER OF THE BUTTONS HAD NORMAL RESPONSE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE BUTTONS. THE DISPLAY WAS NOTED TO BE DIM AND DISCOLORED AND WAS DIFFICULT TO READ. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY WITHOUT DISCOLORATION.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THE DOWN ARROW AND OK BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE HARD PRESSES TO ENGAGE. 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
    245244 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR