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

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/11/2021

Event Type  malfunction  

Event Description

It was reported that an unknown dexcom issue occurred.Data was evaluated and the allegation was confirmed as signal loss greater than an hour was confirmed.The sensor was inserted into an unknown insertion side on an unknown insertion date.The probable cause was determined to be signal loss.The probable cause of the signal loss could not be determined.The reported event of an unknown dexcom issue is reportable based on the finding of signal loss greater than an hour.No injury or medical intervention was reported.

Manufacturer Narrative

Patient was unable to identify device issue therefore a more specific code could not be selected.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an unknown dexcom issue occurred.Data was evaluated and the allegation was confirmed as signal loss greater than an hour was confirmed.The sensor was inserted into an unknown insertion side on an unknown insertion date.The probable cause was determined to be signal loss.The probable cause of the signal loss could not be determined.The reported event of an unknown dexcom issue is reportable based on the finding of signal loss greater than an hour.No injury or medical intervention was reported.

• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 13178614
• MDR Text Key: 285612914
• Report Number: 3004753838-2022-001841
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female