MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	MT22949
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on 08/12/2017, that on (b)(6) 2017, the patient reported no readings on the receiver for more than 3 hours.No medical intervention was reported.Additional event or patient information is not available.The device has been received for evaluation.A follow-up report will be submitted once the evaluation is complete.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient reported no readings on the receiver for more than 3 hours.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Upon further review, it was determined that the receiver is a non-commercial product line that was not in commercial distribution during the time of event; therefore making this a non-reportable event.Please disregard the complaint reported in mfr# 3004753838-2017-65380.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 6841907
• Report Number: 3004753838-2017-65380
• Device Sequence Number: 16346257
• Product Code: PQF
• UDI-Device Identifier: 00386270000231
• UDI-Public: 00386270000231
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2017

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: MT22949
• Device Catalogue Number: STK-SD-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2017
• Supplement Date Received by Manufacturer: 09/18/2017; 10/18/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 10/12/2017; 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1