MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR

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

Patient Problem Cardiac Arrest (1762)

Event Date 10/30/2016

Event Type  Death  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on 11/17/2016 that on (b)(6) 2016, that the patient passed away.Patient's wife reported that the patient passed away at home due to cardiac arrest.Emergency medical technicians (emts) arrived and the patient's body was transported to a hospital.A copy of the certificate of death was not provided.The patient was not wearing the continuous glucose monitor (cgm) at the time of death.There was no alleged device malfunction.Additional event or patient information is not available.No product or data was provided for evaluation.The customer complaint could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

A receiver (part number stk-gf-001/serial number (b)(4)/lot number 5220275) was returned for evaluation.A visual inspection was performed and no defects were found.Functional testing was performed and no failures were detected.A review of the data log did not find any errors.Additionally, a transmitter (part number stt-gf-001/serial number (b)(4)/lot number 5216445) was returned for evaluation.A visual inspection was performed and no defects were found.Functional texting and a pairing test was performed and the tests passed.The devices were determined to be operating within the required specifications without malfunction.There was no allegations to the devices.

• Brand Name: NI
• 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: 6153324
• MDR Text Key: 61693141
• Report Number: 3004753838-2016-52895
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 58 YR