MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM 6 SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number 9500-45

Device Problem Noise, Audible (3273)

Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)

Event Date 07/24/2020

Event Type  Injury  

Event Description

I was installing a dexcom 6 sensor which i have done may times before and when i installed it yesterday, it gave a very long "bang" noise when i pushed the install orange button down.Immediately it began to hurt at the insertion site and that pain increased over time.I called dexcom and was told to remove said device and i did.It made a welt on the insertion site and a large knot under the skin at the insertion site.Fda safety report id# (b)(4).

• Brand Name: DEXCOM 6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10338204
• MDR Text Key: 201045072
• Report Number: MW5095772
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• 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: 07/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/06/2021
• Device Model Number: 9500-45
• Device Lot Number: 5275307
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 107