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

Model Number	MT22495-PNK
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	10/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Diabetes mellitus is a known cause of loss of consciousness.
Event or Problem Description
Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced an intermittent audio alert and an adverse event.At 6:00am the patient missed an audio alert on the receiver and passed out.The patient's husband called 911 because he was unable to wake the patient up.When the emergency medical technician's (emt) arrived, they checked the patient's blood glucose (bg) meter reading and the value was 28 mg/dl.The emts administered the patient with intravenous (iv) glucose therapy.The patient regained consciousness at 6:30am.It was indicated that the patient was not taken to the hospital.At the time of contact, the patient was in stable condition.No additional patient or event information is available.The receiver was received for evaluation.An exterior visual inspection was performed, and the inspection passed.The receiver was charged and rebooted.A review of the downloaded data log did not observe any errors related to the customer complaint.Functional testing was performed, and the tests passed.A manual try it test was performed and the test passed.The receiver was opened for further evaluation.An internal visual inspection was performed, and the inspection passed.An intermittent speaker audio and resistance test was performed, and the tests passed.The reported event of intermittent audio output was not confirmed.A root 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 drive; san diego CA 92121
• MDR Report Key: 7047349
• Report Number: 3004753838-2017-46247
• Device Sequence Number: 11102110
• Product Code: MDS
• UDI-Device Identifier: 20386270000167
• UDI-Public: 20386270000167
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/25/2017

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: MT22495-PNK
• Device Catalogue Number: STK-RR-PNK
• Device Lot Number: 5219359
• 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: 10/25/2017
• Initial Report FDA Received Date: 11/20/2017
• 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: 60 YR
• Patient Weight: 51