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

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

Patient Problems Stroke/CVA (1770); Hypoglycemia (1912); Seizures (2063); Loss of consciousness (2418)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced an adverse event.The patient's mother reported that the patient required medical attention while wearing the dexcom continuous glucose monitoring (cgm) system.The patient's roommate found the patient unresponsive after a day of not moving and/or sleeping.The patient's roommate called the paramedics, who administered glucagon and transported the patient to the emergency room (er).Upon arrival, the patient was still unconscious and started seizing.The patient was then moved to the intensive care unit (icu) and testing concluded that the patient's unresponsive state was due to 3 mini strokes caused by a lack of sugar to the brain.On (b)(6) 2016, the patient started showing signs of responsiveness and was transferred over to outpatient rehabilitation on (b)(6) 2016.The patient was in outpatient rehabilitation for 10 days, where she showed improvement on her occupational and physical therapy.There was no alleged device malfunction.At the time of contact, the patient was stable.Additional event or patient information was not provided.No product or data was provided for evaluation.The reported event could not be 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: 6058039
• MDR Text Key: 58413465
• Report Number: 3004753838-2016-80620
• 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: Other
• Type of Report: Initial
• Report Date: 10/03/2016

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2016
• Initial Date FDA Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 19 YR
• Patient Weight: 68