MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; SENSOR, GLUCOSE, INVASIVE

Model Number G6

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hypoglycemia (1912)

Event Date 05/19/2021

Event Type  Injury  

Event Description

My husband, (b)(6) was driving and had a low blood sugar event.He went off the road into a deep ditch.Luckily he wasn't hurt and did not injure anyone.He was transported to the hospital after being treated for low blood sugar on the scene to ensure that he did not have a stroke or cardiac event.He was negative for both.Upon seeing his doctor we learned that the event was caused by a malfunctioning sensor (dexcom g6) used with his tandem t:slim x2 insulin pump.His sensor was reading his blood sugar as 400 when finger sticks that morning were 42! we notified both companies: dexcom and tandem of the incident.Apparently tandem has a contract with dexcom and asked for the data to review.We provided this and they got back to us several days later and concurred that the sensor had malfunctioned.We asked them for a letter indicating that the cause of the incident was not my husband, as dmv suspended his license due to this.They indicated by email several times that they were working on a letter but we never received it.Dmv gave my husband back his license based on the data provided from our physician showing the pump malfunction and the fact that he is well controlled with an a1c of 6.6.I am concerned and wanted to make sure that they did report this incident as we were very lucky that nothing catastrophic happened that day.Other than this incident the pump has worked well for my husband but if there are other incidents that have happened like this it should be looked in to.We can provide the pump data indicating this malfunction as well as other readings from that month, and before and after that incident.This was the 10th day of the sensor and these are replaced every 10 days.We do not have the sensor but do have the pump.We have copies of emails from the company and name of individual from tandem's technical team who requested the data and got back to us.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12312984
• MDR Text Key: 266841579
• Report Number: MW5103185
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2021
• Device Model Number: G6
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 67 YR
• Patient Weight: 100