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 06/07/2018

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, the patient experienced an adverse event.Date of issue is an approximation.The patient stated they passed out from a low event which resulted in the paramedics being called as the receiver did not alert them of their low glucose values.He indicated that the paramedics administered him with glucagon.The patient did not wish to provide further event details.No additional patient information is available.No data or product was provided for evaluation.The complaint confirmation was unable to be determined.A probable cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The receiver 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.A try it test was performed, and the test failed.The receiver case was opened for further evaluation.An interior inspection was performed, and the inspection 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 was 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: 7681801
• MDR Text Key: 113776797
• Report Number: 3004753838-2018-076241
• 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,Followup
• Report Date: 06/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• 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: 5235062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2018
• 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: 71 YR