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

Model Number MT22495

Device Problem Defective Alarm (1014)

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

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, an intermittent audio output and an adverse event was reported.Date of issue is an approximation.The patient stated they experienced a low blood glucose event in which they became comatose.The patient indicated that the receiver did not provide alerts.Emergency medical technician¿s (emts) were called and transported the patient to the hospital via ambulance.During the ambulance ride, the patient was treated with intravenous (iv) therapy of glucose and they recovered consciousness in the ambulance.The patient was admitted to the emergency room (er) and released the same day.At the time of contact, the patient had recovered from the event.No additional patient or event information is available.The complaint device was returned for evaluation.An exterior physical visual inspection was performed, and no defects were found.The receiver was charged and rebooted successfully.A review of the downloaded receiver log did not find any errors related to the customer complaint.Functional testing was performed, the test passed.The receiver case was opened for further evaluation.An interior inspection was performed, and the inspection passed.A try it test was performed, and the test passed.The receiver was tested on the global receiver communication tool and the test passed.The resistance of the speaker was measured, and the resistance was within specification.The reported intermittent audio output could not be confirmed.A probable 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 dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 7783039
• MDR Text Key: 117119572
• Report Number: 3004753838-2018-092059
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 30386270000157
• UDI-Public: 30386270000157
• 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
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STR-DR-001
• Device Lot Number: 5232899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• 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): Other
• Patient Age: 79 YR
• Patient Weight: 77