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

Model Number MT22719-PNK

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Seizures (2063); Vomiting (2144); Concussion (2192)

Event Date 11/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). Diabetes mellitus is a known cause of hypoglycemia and its associated effects.

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced err121 and a hypoglycemic event. Patient's mother reported that due to the receiver displaying the error icon, they were unable to get values and the patient had an urgent low. Patient was taken to the emergency room and was vomiting, had a seizure and a concussion due to a low blood glucose value of 30mg/dl. The patient was given ibuprofen and zofran. Patient was released from the hospital the same day. At the time of contact, the patient was doing well. Additional event or patient information is not available. No product or data was returned for evaluation. The reported event of error icon displayed 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: 6136119
• MDR Text Key: 61149512
• Report Number: 3004753838-2016-52774
• Device Sequence Number: 1
• Product Code: MDS
• 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
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MT22719-PNK
• Device Catalogue Number: STK-GF-PNK
• Device Lot Number: 5214663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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: 11/30/2016 Patient Sequence Number: 1