MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number MT20649

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Seizures (2063); Loss of consciousness (2418)

Event Date 03/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of loss of consciousness and seizures.

Event Description

Patient contacted dexcom on (b)(6) 2016 to report an adverse event that occurred on (b)(6) 2016.Patient had a seizure and was unconscious for 45 minutes.After waking up she called 911.The fire department arrived at her home approximately 20 minutes later, administered glucose gel to bring the patient's sugar levels up and checked her vitals.Paramedics continued to check the patient's blood pressure as it was very low.Patient refused to be taken to the hospital and paramedics stayed until she was stable, which was approximately 30-45 minutes later.Patient was using the dexcom continuous glucose monitor (cgm) and the time of the event but was unsure if issue was related to the cgm.At the time of contact, the patient had recovered well and the cgm system was working normally.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5546514
• MDR Text Key: 41817604
• Report Number: 3004753838-2016-02194
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000064
• UDI-Public: (01)00386270000064(241)MT20649(10)5197674(17)NA
• 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: 03/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT20649
• Device Catalogue Number: STR-GL-001
• Device Lot Number: 5197674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2014
• 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: 32 YR
• Patient Weight: 63