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

Model Number MT20649-2

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

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 root cause could not be determined.No injury or medical intervention was reported.

Manufacturer Narrative

(b)(4).

Event Description

The product was evaluated.An external visual inspection was performed and passed.The receiver charge and boot up passed.The receiver download retrieve and attach passed.The receiver functional test station passed all tests.The log was downloaded and reviewed finding no errors related to the complaint.Global receiver communication tool audio and vibration tests were performed and passed."try it" audio/vibration tests were performed and all alert/alarm tests passed.The receiver case was opened for an internal visual inspection and it passed.The speaker audio and vibrator intermittent tests were performed and passed.The speaker and vibrator resistance was measured and passed because speaker and vibrator resistance measured within specification.The allegation was not confirmed.The 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 drive; san diego, ca CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego, ca CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence drive; san diego, ca, CA 92121 ; 8582000200
• MDR Report Key: 8589117
• MDR Text Key: 144686787
• Report Number: 3004753838-2019-40097
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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,Followup
• Report Date: 03/05/2020

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: MT20649-2
• Device Catalogue Number: STK-GL-117
• Device Lot Number: 5236954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 02/08/2020
• Supplement Dates FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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