BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE SYSTEM

    MDR report key: 5243979 · Received November 23, 2015

    Report

    Report Number
    3004753838-2015-87653
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    October 30, 2015
    Report Date
    October 30, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    OYC
    UDI-DI
    00386270000019
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED ON (B)(6) 2015, AND THE INACCURACY WAS NOTICED ON (B)(6) 2015. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE. IT WAS REPORTED THAT THE PATIENT INSERTED THE SENSOR INTO THE ARM WHICH IS NOT AN APPROVED SITE ACCORDING TO THE USER'S GUIDE. IT SHOULD BE NOTED THAT THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: SENSOR PLACEMENT AND INSERTION IS NOT APPROVED FOR SITES OTHER THAN THE BELLY (ABDOMEN). IT WAS REPORTED THAT THE PATIENT HAD TAKEN MEDICATION(S) THAT CONTAIN ACETAMINOPHEN. IT SHOULD BE NOTED THAT THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: MAKE SURE YOU HAVE NOT TAKEN ANY MEDICATIONS CONTAINING ACETAMINOPHEN (SUCH AS TYLENOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774691 ANIMAS VIBE SYSTEM OYC OYC DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR