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

Model Number 9500-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Hyperglycemia (1905); Rash (2033)

Event Date 10/24/2020

Event Type  Injury  

Event Description

A patient called to report his adverse effects from a g6 sensor.Reporter said previously he experienced a chemical burn from dexcom sensor but this time it caused him hives.He said there are welts on his back, legs and arms.He also said the doctor puts him on steroid for his condition and as a result his blood glucose went up.

• Brand Name: G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10829566
• MDR Text Key: 216219625
• Report Number: MW5097814
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9500-45
• Device Lot Number: 7277657
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 77