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

Model Number MT22608

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018 that on (b)(6) 2018, the receiver had intermittent audio output.It was reported that an adult patient was using a pediatric receiver.Labeling indicates: the dexcom g4 platinum (pediatric) continuous glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes.No product was provided for evaluation.The complaint confirmation of the receiver having intermittent audio output could not be determined.A probable cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The receiver was returned for evaluation.An exterior visual inspection was performed and passed.The receiver was charged and will boot.The receiver log was downloaded and reviewed, finding no errors related to the complaint.A receiver functional test was performed and passed all relevant testing.A global communication tool software test was performed and passed.Wiggle testing was performed and passed.Manual "try it" testing was performed and passed.The receiver case was opened for an interior inspection and passed.Speaker resistance was measured and was within specification.The reported event of an intermittent audio output was not confirmed.A probable cause could not be determined.

• 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: 8157293
• MDR Text Key: 130111621
• Report Number: 3004753838-2018-155915
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000184
• UDI-Public: 10386270000184
• 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: 12/12/2018

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: MT22608
• Device Catalogue Number: STK-PR-001
• Device Lot Number: 5233480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2018
• 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: 82 YR