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

Model Number MT20649-1

Device Problem No Audible Alarm (1019)

Patient Problem Hypoglycemia (1912)

Event Date 07/06/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia.

Event Description

It was reported that the receiver had no audio output.The patient experienced a hypoglycemic event and had not received an audio alert from the receiver.No information was provided concerning the cgm and bg values, what occurred, if medical intervention was required and the alert settings.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No additional patient or event 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 ; 8582036280
• MDR Report Key: 8888963
• MDR Text Key: 154163530
• Report Number: 3004753838-2019-59635
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• 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: 5241059
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• 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 Outcome(s): Other