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

Model Number	MT22608-PNK
Medical Device Problem Code	Device Inoperable (1663)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017 the receiver ceased to function.No additional event or patient information is available.The receiver was returned for evaluation.An exterior visual inspection was performed and passed.The receiver was charged to see if it would boot up normally, and it failed.A functional test was attempted, but it could not be completed.The data log could not be obtained for review as the recevier could not be turned on.The receiver case was opened for an internal visual inspection, and passed.A voltage test was performed and failed.Through trouble-shooting a defective u6 component was found.The reported event that the receiver ceased to function was confirmed.The root cause was determined to be a defective u6 component.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM INC.; 6340 sequence dr; san diego CA 92121
• MDR Report Key: 7003310
• Report Number: 3004753838-2017-94921
• Device Sequence Number: 19086047
• Product Code: MDS
• UDI-Device Identifier: 20386270000198
• UDI-Public: 20386270000198
• 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
• Report Date (Section B): 10/08/2017

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-PNK
• Device Catalogue Number: STK-CR-PNK
• Device Lot Number: 5219688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2017
• Initial Report FDA Received Date: 11/06/2017
• 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