MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT20649-1

Device Problem Defective Alarm (1014)

Patient Problem Hypoglycemia (1912)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient experienced intermittent audio output and an adverse event.The patient reported on the morning of (b)(6) 2019, they experienced a hypoglycemic event with no symptoms and they did not receive an audio alert from the continuous glucose monitor (cgm) receiver.Patient discovered they had low blood glucose levels upon taking a fingerstick reading.Later in the afternoon, the patient had high glucose levels and they also did not receive an audio alert.Patient's blood glucose readings and cgm readings were not provided.No data or product was provided for investigation.Confirmation of the allegation was undetermined.The root cause could not be determined.No additional event or patient information is available.

• Brand Name: DEXCOM G4 PLATINUM 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: ying chen ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8857402
• MDR Text Key: 153159984
• Report Number: 3004753838-2019-57600
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT20649-1
• Device Catalogue Number: STK-GL-007
• Device Lot Number: 5241852
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 08/02/2019
• 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