BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4600980 · Received March 13, 2015

    Report

    Report Number
    3004753838-2015-01954
    Event Type
    Malfunction
    Date Received
    March 13, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 17, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT INTERMITTENT OUT OF RANGE SIGNAL ON (B)(6) 2015. DEXCOM TECHNICAL SUPPORT ADVISED PATIENT TO PERFORM RESET ON DEVICE. PATIENT IS USING DEXCOM CONTINUOUS GLUCOSE MONITORING (CGM) AND THE ANIMAS VIBE PUMP ALONG WITH A SINGLE-BOARD TRANSMITTER (SBT) WITH VIBE SYSTEM WHICH IS AGAINST USER GUIDE RECOMMENDATIONS. THE PATIENT DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176204 ANIMAS INSULIN INFUSION PUMP OYC OYC DEXCOM, INC. 9438-05

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR ANIMAS INSULIN INFUSION PUMP