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

Model Number 9438-06

Device Problem Wireless Communication Problem (3283)

Patient Problems Dehydration (1807); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report that the patient experienced an adverse event and a loss of connection with both the receiver and smart device on (b)(6) 2016.Patient stated that due to the loss of signal on the receiver and smart phone, he was unaware of his low blood sugar.Patient's wife found him passed out in the bathroom dehydrated and with blood sugar below 40mg/dl.As a result, he was taken to the hospital via ambulance and stayed overnight.While at the hospital, patient was treated with sugar water and fluids.At the time of contact, the patient was in normal condition.Data was provided for evaluation.The reported event of loss of connection was not confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The complaint transmitter device was returned for evaluation.The device was visually inspected and no defect was found.A voltage test was completed and failed.Log review showed the reported event of loss of connection was confirmed.The root cause could not be determined.Upon further review of the initial data investigation the data provided for evaluation confirmed the reported event of loss of connection.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer (Section G): DEXCOM, INC.; 6340 sequence drive; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 5869206
• MDR Text Key: 51860823
• Report Number: 3004753838-2016-80014
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000224
• UDI-Public: (01)00386270000224(241)9438-06(10)5210434(17)NA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

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
• Device Operator: Lay User/Patient
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-001
• Device Lot Number: 5210434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 41 YR
• Patient Weight: 129