BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4150160 · Received October 7, 2014

    Report

    Report Number
    3004753838-2014-29402
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT ADVERSE EVENT AND BROKEN SENSOR WIRE ON (B)(6) 2014. PATIENT'S MOTHER CLAIMED THAT UPON REMOVAL OF SENSOR POD, SENSOR WIRE BROKE OFF IN PATIENT'S SKIN. PATIENT'S MOTHER TOOK PATIENT TO URGENT CARE ON (B)(6) 2014 AND WAS ADVISED TO TAKE PATIENT TO THE ER. PHYSICIAN'S ASSISTANT REMOVED SENSOR WIRE FROM PATIENT'S SKIN AND PRESCRIBED CEPHALEXIN. PATIENT INSERTED SENSOR IN THIGH WHICH IS NOT AN APPROVED SITE. PATIENT REMOVED TRANSMITTER PRIOR TO REMOVAL OF SENSOR POD AGAINST USER GUIDE RECOMMENDATIONS. PATIENT'S MOTHER DID NOT REPORT ANY FURTHER INJURY OR MEDICAL INTERVENTION. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627777 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5189432

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization