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

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, the patient experienced issue with the dexcom system; however, they could not clarify what the issue was.They stated the dexcom was reading high and when they checked their blood sugar, it was in the 500 mg/dl range.They treated themselves with insulin.The patient stated their glucose value was not going down and started feeling tired and had a headache, so they went to the emergency room (er) to get treated.She indicated that she did not receive treatment at the hospital as she had already taken too much insulin and had to wait for the insulin to take in effect to decrease her glucose values.At this time, the patient indicated they had to stop their insulin pump and rely on their glucometer to monitor their values due to having issue with the dexcom.After a few hours, the patient was released from the hospital.At the time of contact, the patient was in stable condition.No additional patient or event information is available.

• Brand Name: DEXCOM G5 MOBILE 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: 7918500
• MDR Text Key: 122032654
• Report Number: 3004753838-2018-115301
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 78 YR