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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bruise/Contusion (1754); Rash (2033); Skin Inflammation (2443)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Reporter has skin inflammation, rash, and bruising from using four of his dexcom g6 cgm sensors.Reporter has contacted the manufacturer and has been sent one replacement sensor.The manufacturer has suggested to the reporter that he tries the suggestions for skin inflammation relief on their website.Reporter has tried several of the suggestions and none of them gave him any relief.He continues to have skin irritation and plans to call dexcom again today.

• Brand Name: DEXCOM CGM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10521256
• MDR Text Key: 206945053
• Report Number: MW5096559
• Device Sequence Number: 2
• Product Code: MDS
• 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: 09/10/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 86