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 03/31/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an intermittent audio output and an adverse event occurred.The patient stated at about 1:00pm, they finished eating lunch and missed a low alert on the receiver.They indicated that he felt the vibration; however, he didn't hear the alert at all.He was cognitive at 70 mg/dl which is what his low was set at and stated he ended up passing out.His wife called the ambulance and the patient was given dextrose via iv during the ambulance ride to the hospital and his blood sugar increased to 80 mg/dl after receiving the iv.The patient remembers coming around when they were getting to the hospital.Patient was held in the hospital until his blood sugar stabilized.At the time of contact, the patient was doing okay.No product or data was provided for evaluation.Confirmation of the allegation and a probable cause could not be determined.No additional patient or event information is available.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an intermittent audio output occurred.The product was evaluated.An external visual inspection was performed and passed.Functional testing was performed and passed.Data was downloaded and a review of the downloaded data log dd not find issues related to the customer complaint.Global receiver communication test was performed and passed.A try-it test was performed and passed.The receiver was opened for further evaluation.An internal visual inspection was performed and passed.A speaker audio test was performed and passed.The speaker resistance was measured and was within specification.The allegation 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: 8603975
• MDR Text Key: 144834604
• Report Number: 3004753838-2019-041317
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 10386270000153
• UDI-Public: 10386270000153
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: STK-DR-001
• Device Lot Number: 5220647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/13/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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: 61 YR
• Patient Weight: 100