BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 4933200 · Received July 22, 2015

    Report

    Report Number
    3004753838-2015-05980
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 26, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION WAS COMPLETED BY (B)(4) ON (B)(6) 2015. INVESTIGATION RESULTS WERE RECEIVED BY DEXCOM ON 07/29/2015. THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO COSMETIC FLAW. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED. EVALUATION OF THE FAILED TRANSMITTER TEST CONFIRMED THE REPORTED EVENT OF AN INTERMITTENT OUT OF RANGE SIGNAL; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 ON FOREIGN PATIENT'S BEHALF TO REPORT INTERMITTENT OUT OF RANGE ON (B)(6) 2015. AT THE TIME OF CONTACT THE DISTRIBUTOR DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475895 ANIMAS VIBE SYSTEM OYC OYC DEXCOM, INC. 9438-05 5198302

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR