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

Lot Number 5290536

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Using dexcom 6 sensors after being applied start to itch day 2, at day ten when removed left with raised, red itchy rash which can last for a month or longer.Seems to be like a yeast rash.Entered one lot number, but has happened with all i've used.Fda safety report id # (b)(4).

• Brand Name: DEXCOM 6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12728316
• MDR Text Key: 279569655
• Report Number: MW5105039
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2022
• Device Lot Number: 5290536
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 99