MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 9500-27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).This mdr is to capture two of the two unspecified severe reactions that was reported.

Event Description

It was documented in a social media post that the patient reported a signal loss and two severe reactions occurred.The patient's husband found her unresponsive and administered two glucagon injections.Information about the two severe reactions and the continuous glucose monitor (cgm) or blood glucose (bg) values was not provided.Neither the patient nor her husband received an alert that there was an issue with the patient's blood glucose or that the follow application was not working.No product or data was provided for investigation.Problem could not be confirmed, and probable cause could not be determined.Per medical review, this report would constitute an adverse event because an allegation against the dexcom system resulted in a hypoglycemic event that required treatment with glucagon.No additional event or patient information is available.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence drive; san diego, CA 92121 ; 8582036280
• MDR Report Key: 9517106
• MDR Text Key: 172695507
• Report Number: 3004753838-2019-112147
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: 00386270000019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2019
• Initial Date FDA Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other