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

Model Number	9500-27
Medical Device Problem Code	Invalid Sensing (2293)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	12/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) diabetes mellitus is a known cause of loss of hypoglycemia.The g5 system is associated with product code pqf.Product code pqf is not currently available in common device name.
Event or Problem Description
Dexcom was made aware on 01/06/2017, that on (b)(6) 2016, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter and an adverse event that occurred.The patient's mother indicated that the cgm displayed a value of 55 mg/dl compared to bg meter value of 34 mg/dl.The patient's mother stated that the patient had dropped from 64 mg/dl with glucose and crackers in a matter of 10 minutes.The patient was given glucose gel and her blood sugar went back up.Additionally, the patient's mother stated that the patient's blood sugar shot up after the event and therefore, was given insulin to get it to come back down.The patient was feeling better within a couple of hours.Data was provided for evaluation.The reported issue of inaccuracies between cgm and fs values was confirmed via data.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Common Device Name: CONTINOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• MDR Report Key: 6300924
• Report Number: 3004753838-2017-01177
• Device Sequence Number: 11017241
• Product Code: MDS
• UDI-Device Identifier: 10386270000016
• UDI-Public: (01)10386270000016(241)9500-27(10)NI(17)NI
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/06/2017

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: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 02/03/2017
• 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: 6 YR