BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5736182 · Received June 20, 2016

    Report

    Report Number
    3004753838-2016-38536
    Event Type
    Injury
    Date Received
    June 20, 2016
    Date of Event
    April 29, 2016
    Report Date
    May 23, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DESCRIBE EVENT OR PROBLEM - ADDITIONAL, IF FOLLOW-UP, WHAT TYPE?: ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.

    Description of Event or Problem · 1

    A RECEIVER (PART NUMBER STK-GL-IUO/SERIAL NUMBER (B)(4)/LOT NUMBER 5204945) WAS RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED RELATED TO THE COMPLAINT. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT CONFIRM THE REPORTED EVENT. A ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONALLY, A TRANSMITTER (PART NUMBER STT-GL-005/SERIAL NUMBER (B)(4)/LOT NUMBER 5203754) WAS ALSO RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THE REPORTED EVENT OF INACCURACIES WAS NOT CONFIRMED WITH THE RETURNED TRANSMITTER. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    STUDY COORDINATOR CONTACTED DEXCOM ON (B)(6) 2016 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES AND AN ADVERSE EVENT THAT OCCURRED ON (B)(6) 2016. STUDY COORDINATOR STATED THAT THE PATIENT HAD A HYPOGLYCEMIC EVENT. PATIENT'S GLUCOMETER DISPLAYED BLOOD GLUCOSE VALUE OF LESS THAN 20MG/DL, WHICH WAS VERIFIED WITH A SAMPLE SENT TO THE CENTRAL LAB. THE CONTINUOUS GLUCOSE MONITOR (CGM) INDICATED THAT THE PATIENT WAS AT 108MG/DL AT THE TIME OF THE EVENT AND DID NOT ALARM FOR LOW GLUCOSE PRIOR. PATIENT WAS ADMINISTERED 2 DEXTROSE 10% BOLUSES. AT THE TIME OF CONTACT, THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT AND WAS CONTINUING TO IMPROVE FROM RESPIRATORY FAILURE. THE PATIENT WAS ON FULL FEEDS AND HAD NOT HAD ANY FURTHER HYPOGLYCEMIC EVENTS. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390329 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5208463 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O