BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 4761070 · Received May 8, 2015

    Report

    Report Number
    3004753838-2015-14313
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 11, 2015
    Report Date
    April 11, 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).

    Description of Event or Problem · 1

    DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT ON BEHALF OF PATIENT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER ON (B)(6) 2015. THE SENSOR WAS INSERTED 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
    302692 ANIMAS VIBE SYSTEM OYC OYC DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR ANIMAS VIBE SYSTEM