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

Model Number DEXCOM 6 SENSOR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 10/01/2020

Event Type  Injury  

Event Description

Causes rash and itching; i wear a dexcom 6 and apparently there were patients who had a problems with itching and severe rash.So dexcom changed the adhesive.Well now that they changed the adhesive i now have the itch and rash.They need to fix this crap.Fda safety report id# (b)(4).

• Brand Name: DEXCOM 6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11265552
• MDR Text Key: 230056260
• Report Number: MW5099133
• 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
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/19/2021
• Device Model Number: DEXCOM 6 SENSOR
• Device Lot Number: 5279889
• 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): Other
• Patient Age: 59 YR
• Patient Weight: 69