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	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on 05/29/2018 that on (b)(6) 2018, the receiver had intermittent audio output.No additional event or patient information is available.The receiver was returned for evaluation.An exterior visual inspection was performed and passed.The receiver log was downloaded and reviewed, finding no data within the investigation window.A global receiver functional test was performed, and it failed the speaker tests.A global communication tool software test could not be performed as the tool could not communicate with the receiver.Manual "try it" testing was performed and failed.The receiver case was opened for an interior inspection and failed.Speaker resistance was measured and failed.The reported event of an intermittent audio output was confirmed.The probable cause was determined to be a defective speaker.

• 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: 7634451
• Report Number: 3004753838-2018-068952
• Device Sequence Number: 1898805
• Product Code: MDS
• UDI-Device Identifier: 30386270000188
• UDI-Public: 30386270000188
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 05/29/2018

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: STR-PR-001
• Device Lot Number: 5204962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 31