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

Model Number STS OR 003

Device Problems Product Quality Problem (1506); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2022

Event Type  malfunction  

Event Description

I use the dexcom 6 sensor.I have been using it for 4 years.Since covid the failure rate has been at least one sensor per month or one out of 3 sensors.I am filing this complaint because i changed sensors yesterday.This morning at approximately 1:45 a.M.Cst my sensor failed and was reading 137 straight up (increasing), then 56 low.I had to finger stick to get the correct reading.I called dexcom and, as usual, they are sending a replacement.I need for these to be accurate.I can't have a false reading, administer insulin through my pump, and over dose.It is a real possibility and could case me significant harm.What can you do to ensure these sensors work accurately.Dexcom has no answers.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: 15242519
• MDR Text Key: 298250378
• Report Number: MW5111528
• 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: 08/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: STS OR 003
• Device Lot Number: 7306133
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: JARDIANCE; LOSARTAN ; NOVALOG; T-SLIM TANDEM PUMP; VASCEPA
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White