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

Device Problems Product Quality Problem (1506); Device Slipped (1584)

Patient Problems Bruise/Contusion (1754); Swelling (2091); Urticaria (2278)

Event Date 04/26/2020

Event Type  Injury  

Event Description

Started using dexcom sensors in (b)(6) 2019, in late (b)(6) 2020 noticed a rash, hives and bruising underneath the sensor.The sensor also, will fall off after about six days and the reporter will have to wear a patch over the sensor to hold it in place."i've been in contact will dexcom and they have sent replacement but, i still have problems with the new one.I don't want to have to spend (b)(6) to replace them.".

• Brand Name: DEXCOM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10173845
• MDR Text Key: 196062737
• Report Number: MW5095082
• 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: 06/18/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR
• Patient Weight: 102