BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4524094 · Received February 18, 2015

    Report

    Report Number
    3004753838-2015-01204
    Event Type
    Malfunction
    Date Received
    February 18, 2015
    Date of Event
    March 6, 2014
    Report Date
    January 21, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DESCRIBE EVENT OR PROBLEM - ADDITIONAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT TRANSMITTER DEVICE WAS NOT RETURNED TO DEXCOM FOR EVALUATION. THE SENSOR ((B)(4)/LOT NUMBER 5131374), BEING USED WITH THE TRANSMITTER DEVICE WAS RETURNED FOR EVALUATION ON 05/19/2015. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. DUE TO THE TRANSMITTER BEING USED WITH THE SENSOR NOT BEING RETURNED, AN INVESTIGATION WAS UNABLE TO BE COMPLETED TO CONFIRM THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED TO ANIMAS FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED BY ANIMAS AND NO COSMETIC FLAW WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED TO DEXCOM FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE TRANSMITTER.

    Description of Event or Problem · 1

    FOREIGN DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 ON PATIENT'S BEHALF TO REPORT PERMANENT OUT OF RANGE ON (B)(6) 2014. FOREIGN PATIENT PERFORM PAPERCLIP RESET SEVERAL TIMES AND IT WAS UNSUCCESSFUL. AT THE TIME OF CONTACT THE FOREIGN DISTRIBUTOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116195 ANIMAS INSULIN INFUSION PUMP OYC OYC DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1