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

Model Number MT22495-BLU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Loss of consciousness (2418); Sudden Cardiac Death (2510)

Event Date 05/22/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of death.

Event Description

Patient's wife contacted dexcom on 05/26/2016 to report that her husband had passed away on (b)(6) 2016.Patient's wife stated that the patient was at the movie theaters when he fell over.Someone (unknown) noticed and called 911.The patient was rushed to the hospital.Wife was unsure what medications were administered if any.Wife is under the impression the patient was unresponsive the entire time.Patient was wearing the continuous glucose monitor (cgm) at time of death.However, there was no alleged device malfunction.No product or data returned for investigation, however, a death certificate was provided which confirmed the event.Root cause was determined to be cardiac arrest and coronary artery disease.Diabetes mellitus was another condition which contributed to death.No additional event or patient information is available.

Manufacturer Narrative

(b)(4) describe event or problem - additional, additional information.

Event Description

The receiver (part number stk-dr-blu/serial number (b)(4)/lot number 5198414) being used at the time of event was returned for evaluation.The device was visually inspected and no defects were found.Functional testing was performed and the test passed.The data log was downloaded and reviewed and found no observations related to the event.Additionally, two transmitters (lot number 5210724 and lot number 5197155) were returned for evaluation.The products were visually inspected and no defects were found.Functional testing was performed and both tests passed.There was no alleged malfunction reported for the returned devices.No further patient or event information is available.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
• Type of Device: MDS
• 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: 5749808
• MDR Text Key: 48188125
• Report Number: 3004753838-2016-03515
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000170
• UDI-Public: (01)00386270000170(241)MT22495-BLU(10)5198414(17)NI
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22495-BLU
• Device Catalogue Number: STK-DR-BLU
• Device Lot Number: 5198414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR