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

Model Number MT22495

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the receiver had intermittent audio output.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

The receiver was evaluated.An external visual inspection was performed and passed.Charge and boot testing was performed and passed.The receiver log was downloaded and reviewed, finding no errors related to the complaint.Functional testing was performed and passed all relevant testing.Audio\vibration test with global receiver communication tool test was performed and passed.Manual try-it audio\vibration testing was performed and passed.The receiver was opened and an internal visual inspection was performed and passed.Speaker audio and vibrator intermittent tests were performed and passed.Speaker and vibrator resistance were measured and were within specification.The allegation was not confirmed.A probable cause could not be determined.No injury or medical intervention was reported.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8750707
• MDR Text Key: 149854982
• Report Number: 3004753838-2019-051211
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000153
• UDI-Public: 10386270000153
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STK-DR-001
• Device Lot Number: 5249466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• 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: 38 YR
• Patient Weight: 69