MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number MT22719

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

Patient Problems Hypoglycemia (1912); Cognitive Changes (2551)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2017 that on (b)(6) 2017, the patient experienced an adverse event.Patient reports that he was at home on his recliner.Patient's continuous glucose monitor (cgm) was next to him.Patient alleges that the cgm did not alert for a low and experienced a hypoglycemic event.Patient's girlfriend found patient on his knees unresponsive.Patient's girlfriend called paramedics.When paramedic arrived, the patient was on his knees and the cgm was on the recliner.The ambulance picked up the patient, then the cgm alerted for an urgent low.Patient was treated with dextrose 50% and glucagon 15g.Patient's blood glucose (bg) was at 228 mg/dl when he was taken to emergency room.Additionally, the patient tested the alert function of the receiver and the audio alert did work.At time of contact, patient is well.No additional event or patient 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 device was returned for evaluation.The device was visually inspected and no defect was found.Functional testing was not performed due to the receiver self re-intialization continuously.The receiver case was opened for internal inspection and passed.The reported event of an intermittent audio output was not confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE 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: 6404384
• MDR Text Key: 69945435
• Report Number: 3004753838-2017-15938
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 30386270000232
• UDI-Public: (01)30386270000232(241)STR-GF-001(10)5220719
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STR-GF-001
• Device Lot Number: 5220719
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• 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: 51 YR
• Patient Weight: 110