BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210918 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09794
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 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

    ON EXAMINATION, THE KEYPAD WAS INTACT WITHOUT DAMAGE. ON TESTING, THE UP ARROW BUTTON 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 THE UP ARROW AND CONTRAST BUTTONS. THE AUDIO BOLUS BUTTON WAS NOTED TO BE UNRESPONSIVE ON TESTING. THE BUTTON COVER WAS REMOVED FOR INVESTIGATION AND REVEALED THE BUTTON SLUG WAS MISSING. THE DISPLAY WAS NOTED TO BE FADED AND DISCOLORED. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEAL MOISTURE THROUGHOUT THE INTERIOR OF THE PUMP AND ON THE DISPLAY CONNECTOR.

    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.

    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 THAT THE BUTTONS ON TYHE PUMP WERE NOT RESPONDING TO PRESSES. THE REPORTER CONFIRMED THAT THE KEYPAD WAS INTACT WITH NO CRACKS OR PEELING NOTED. 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
    309576 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR