MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G6 SENSORS; SENSOR, GLUCOSE, INVASIVE

Model Number DEXCOM G6

Device Problems Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); Ambient Temperature Problem (2878); Device Sensing Problem (2917)

Patient Problem Hyperglycemia (1905)

Event Date 01/03/2021

Event Type  Injury  

Event Description

On (b)(6) 2021; automatic refill was sent without my consent or order.Refill package was left on my porch, and left over the new years holiday, sent by byram healthcare, without any insulation to ensure sensors remained within dexcom's stated safe temperature range (36f-80f).On (b)(6) 2021, i initiated a sensor session with a sensor from the box that had been left out in the cold.Throughout the day yesterday, (b)(6) 2021, i repeatedly encountered no-readings alerts as well as sensor errors (upper 300s).As i knew that my sensors' safety may have been compromised, and because my readings were so high, i ended my sensor session early and selected a sensor that i knew had been stored properly, and i proceeded with a different session.I did complete a tech support report for dexcom (b)(4).Erratic readings with sensors included in shipment.Quantity 9 sensors.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 11321459
• MDR Text Key: 232183376
• Report Number: MW5099359
• Device Sequence Number: 8
• Product Code: MDS
• Combination Product (y/n): Y
• 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: 02/09/2021
• 9 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DEXCOM G6
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 64