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

Model Number	MT22719
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that an intermittent audio output occurred.Date of issue is an approximation.The patient stated that at 5:00 am, her husband found her unresponsive and called emergency medical services (ems).The paramedics started an iv and administered iv glucose.Her cgm and bg values at the time the paramedics arrived were not provided.She was treated at home and the paramedics left when her bg was 198 mg/dl.She alleged that the receiver did not alert her that her bg was dropping or that it was low.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No additional patient or event information is available.

• 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: 9186744
• Report Number: 3004753838-2019-072479
• Device Sequence Number: 2172226
• Product Code: PQF
• UDI-Device Identifier: 20386270000235
• UDI-Public: 20386270000235
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STK-RF-001
• Device Lot Number: 5230624
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 73