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

Model Number	MT22608-BLU
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
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 no vibration.No additional event or patient information is available.The receiver has been received for evaluation.A follow up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The receiver was returned for evaluation.An external visual inspection was performed and passed.The receiver was charged and will boot.The receiver data log was downloaded and reviewed, and no issues were observed related to the complaint.A global receiver functional test was performed and resulted in no failures related to the reported event.A manual "try-it" test was performed and passed.A global communication tool software test was performed and passed.A vibrator intermittent test was performed and passed.An internal visual inspection was performed and passed.Vibrator resistance was measured and found to be within specification.The reported event of no vibration 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: 7797329
• Report Number: 3004753838-2018-094657
• Device Sequence Number: 18878533
• Product Code: MDS
• UDI-Device Identifier: 10386270000207
• UDI-Public: 10386270000207
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 07/27/2018

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-BLU
• Device Catalogue Number: STK-PR-BLU
• Device Lot Number: 5224403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR