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

Model Number	MT22608
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• MDR Report Key: 8157293
• Report Number: 3004753838-2018-155915
• Device Sequence Number: 295959
• Product Code: MDS
• UDI-Device Identifier: 10386270000184
• UDI-Public: 10386270000184
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR