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

Lot Number 7272740

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 06/04/2020

Event Type  malfunction  

Event Description

Dexcom has recently started using a different adhesive and gave no warning to the users that the adhesive could cause an allergic reaction, causing hives/rash.The unit used to inject the sensors are getting stuck on patients bodies.Dexcom is not changing anything, they just keep sending out new sensors as replacements and not changing anything with the product.Sometimes the needle will not retract from the skin and it is difficult to remove from the body.Uploaded pics should not be shared with any public entity.Fda safety report id# (b)(4).

• Brand Name: DEXCOM CONTINUOUS GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10137867
• MDR Text Key: 194862484
• Report Number: MW5094914
• Device Sequence Number: 1
• Product Code: MDS
• 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: 06/07/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2021
• Device Lot Number: 7272740
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR