BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3260428 · Received August 1, 2013

    Report

    Report Number
    3004753838-2013-00205
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    June 29, 2013
    Report Date
    July 5, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013, PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. PATIENT REPORTS THAT HE PASSED OUT, BUT WAS ABLE TO CALL AN AMBULANCE AFTER AN HOUR. PATIENT RECALLS HEARING THE CGM LOW ALERT AND SEEING A CGM VALUE OF 58 MG/DL PRIOR TO INCIDENT. PATIENT DID NOT CONFIRM THE CGM VALUE, HOWEVER HE REPORTS CONCERN THAT THE SENSOR MAY HAVE BEEN INACCURATE AT THE TIME OF INCIDENT. THE PARAMEDICS ARRIVED AND TRANSPORTED THE PATIENT TO A HOSPITAL. MEDICAL PERSONNEL ADMINISTERED IV AND GLUCOSE TO THE PATIENT BEFORE HE WAS RELEASED. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT REPORTS BEING IN FINE AND HEALTHY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360639 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5065768

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O