BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3132107 · Received May 29, 2013

    Report

    Report Number
    2531779-2013-07110
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 07/23/2013 DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD WAS TORN OF BELOW THE DOWN ARROW BUTTON AND THE OK BUTTON WAS MISSING. THE KEYPAD COVER WAS ALSO TORN ON BOTH SIDES OF THE DOWN ARROW BUTTON TO THE UP ARROW BUTTON. ON TESTING, THE CONTRAST BUTTON HAD NORMAL RESPONSE. THE REMAINDER OF THE BUTTONS WERE NOT FUNCTIONAL. THE CONTACTS FOR THE UP ARROW, DOWN ARROW AND OK BUTTONS WERE MISSING. THERE WAS CONTAMINATION UNDER THE CONTACT OF THE CONTRAST BUTTON. THE DISPLAY WAS NOTED TO BE FADED AND DISCOLORED. A TEST DISPLAY WAS ATTACHED TO THE PUMP AND ILLUMINATED PROPERLY WITHOUT DISCOLORATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. THE REPORTER STATED THAT THE OK KEYPAD BUTTON WAS TORN AND UNRESPONSIVE. THE REPORTER ALLEGED THAT THE RESPONSE ISSUES HAD OCCURRED FIRST. 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
    235502 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR