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

Model Number 9438-05

Device Problem Wireless Communication Problem (3283)

Patient Problems Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced a loss of connection and an adverse event. Date of issue is an approximation. The patient stated that they had signal loss on their device that resulted in a hypoglycemic event. It was indicated that the patient passed out and started seizing. The patient's wife administered 2 units of glucagon and the paramedics were not called. At the time of contact, the patient was doing fine. No additional patient or event information is available. The device has been received for evaluation.   a follow-up report will be submitted once the evaluation is complete.  .

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 performed and it passed. A functional test was performed and it failed continuity. The reported event loss of connection was confirmed. The root cause could not be determined.

• Brand Name: DEXCOM G4 PLATINUM 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: 6907809
• MDR Text Key: 87983544
• Report Number: 3004753838-2017-86138
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000047
• UDI-Public: 10386270000047
• 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

• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9438-05
• Device Catalogue Number: STT-GL-003
• Device Lot Number: 5225041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/02/2017 Patient Sequence Number: 1