BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3110129 · Received May 13, 2013

    Report

    Report Number
    2531779-2013-06295
    Event Type
    Malfunction
    Date Received
    May 13, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: 07/11/2013.DEVICE EVALUATION: ON EXAMINATION, THE KEYPAD COVER WAS INTACT. ON TESTING, ALL THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE KEYPAD COVER WAS REMOVED FOR INVESTIGATION AND REVEALED CONTAMINATION UNDER THE CONTACTS OF ALL THE BUTTONS. THE AUDIO BOLUS BUTTON WAS NOTED TO BE TORN IN THE CENTER. THE AUDIO BOLUS BUTTON WAS RESPONSIVE WHEN TESTED. THE DISPLAY WAS NOTED TO BE DIM 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 CHANGES/UNRESPONSIVE) ISSUE. 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
    211586 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1