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

Model Number 9500-45

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event problem and evaluation codes: patient was unable to identify device issue therefore a more specific code could not be selected.

Event Description

It was reported that replace sensor now alert occurred.Data was evaluated and the allegation was not confirmed.A probable cause could not be determined.However an early sensor expiration due to potential patient misuse was found on (b)(6) 2020.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that replace sensor now alert occurred.Data was evaluated and the allegation was not confirmed.A probable cause could not be determined.However an early sensor expiration due to potential patient misuse was found on (b)(46) 2020.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: 9830073
• MDR Text Key: 185712403
• Report Number: 3004753838-2020-024730
• 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,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-45
• Device Catalogue Number: STS-OR-001
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2020
• 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: 44 YR
• Patient Weight: 62