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

Model Number	MT22719-BLU
Medical Device Problem Code	Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the receiver initialized without a manual restart.Product was received but is pending evaluation.A follow up report will be submitted upon completion.No injury or medical intervention was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the receiver initialized without a manual restart.The product was evaluated.An external visual inspection was performed and passed.A receiver charge and boot was performed and failed due to receiver perpetually rebooting.A receiver download was performed and no data was provided for evaluation.The receiver case was opened, and an internal visual inspection was performed and passed.Confirmation of the allegation and probable cause could not be determined.No injury or medical intervention was reported.

• Brand Name: DEXCOM G5 MOBILE 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: 9136895
• Report Number: 3004753838-2019-069637
• Device Sequence Number: 2694450
• Product Code: PQF
• UDI-Device Identifier: 20386270000273
• UDI-Public: 20386270000273
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/21/2019

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: MT22719-BLU
• Device Catalogue Number: STR-GF-BLU
• Device Lot Number: 5220740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR