MAUDE Adverse Event Report: DEXCOM, INC DEXCOM G5 PLATINUM; SENSOR, GLUCOSE, INVASIVE

Model Number G5 PLATINUM

Device Problems Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)

Event Date 02/03/2019

Event Type  Injury  

Event Description

On february 3rd, i inserted my dexcom g5 platinum cgm sensor on my arm in the tricep reason per usual.After activating the sensor, i received a "sensor error¿ on the receiver, so i restarted it and tried again.I received another sensor error so i removed the sensor from my arm and i noticed the filament was not attached to the sensor.At the time i figured it never was introduced into my skin and i left it alone, put another dexcom on my other arm which worked correctly.The next few days i went about life as normal, working on cars and intensive physical activity and i noticed discomfort in my arm so i chalked it up to being sore.Came friday, february 8th, i hadn¿t been doing physical and intensive activities for two days and the discomfort in my arm progressed to nerve pain and a constant ache in that arm, so i assumed a foreign object (the dexcom g5 filament) was stuck in my arm.I went to (b)(6) hospital emergency room where i was x-rayed.The doctors and nurses noticed the filament had curved and dug itself through my tricep in very close proximity to my humerus bone.Doctors stated it was far too deep for them to attempt to take out at the hospital and suggested two orthopedic surgeons to consult with as outpatient.I have yet to speak with an orthopedic surgeon, i will be tomorrow the 12th of february, but the doctors stated that surgeons might not attempt to take it out as they don¿t want to damage an (b)(6)-year old¿s muscle because it could do more harm than good, and also stated that if it were a bullet fragment or a needle then they would leave it.There are a large number of outcomes that can occur.Surgery with success and no damage, surgery with muscle damage, my body encapsulated the foreign body and i live with or without pain and with or without limited range of movement.No one can give me any affirmative answers at this time.

• Brand Name: DEXCOM G5 PLATINUM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC
• MDR Report Key: 8336813
• MDR Text Key: 136863550
• Report Number: MW5084000
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G5 PLATINUM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 70