MAUDE Adverse Event Report: DEXCOM, INC.; CONTINUOUS GLUCOSE MONITOR

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

Patient Problems Hypoglycemia (1912); Coma (2417); Loss of consciousness (2418)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia.The reported inaccuracies is being reported under mfr 3004753838-2017-75572.

Event Description

Dexcom was made aware on 08/04/2017, that on (b)(6) 2017, the patient experienced a hypoglycemic event.It was reported that the patient texted her husband while he was at work around 12:40pm, that she was going to disconnect the dexcom due to it being inaccurate.The patient's husband stated that when he got home at around a quarter to 5:00pm, he found the patient unconscious.He called 911 and when the paramedics arrived, they administered the patient with an intravenous (iv) but the patient was still not responding.The patient was transported to the hospital and it was indicated that the patient was in a diabetic coma for about 3 weeks.The patient was released on (b)(6) 2017 and was still having trouble remembering things and having trouble speaking.The patient stated that because she was having inaccurate readings, she was not wearing the dexcom system at the time of event.At the time of contact, the patient was at home recovering.No additional patient or event information is available.

• Brand Name: NI
• 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: 6818094
• MDR Text Key: 83605907
• Report Number: 3004753838-2017-73485
• 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: 08/04/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 69