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

Catalog Number UNKNOWN

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

Patient Problems Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 01/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016, to report that she had to remove 2 sensors due to an episode of diabetic ketoacidosis that occurred on (b)(6) 2016.Patient reported that all aspects of her dexcom continuous glucose monitor (cgm) were working properly at the time of the reported event.Patient had to remove sensors only for tests that were done at the hospital.Patient reported that she had been taking antibiotics for a cold at the time of the reported event.Patient also reported taking several other medications.Patient's cold got worse and turned into a stomach bug.Patient was found unconscious on the bathroom floor by a family member on (b)(6) 2016.Patient was driven to the emergency room (er) nearby, where hospital staff gave her anti-nausea medication and insulin after disconnecting the patient's cgm and pump.Patient was admitted into the hospital for diabetic ketoacidosis.Patient was released from the hospital the next day, (b)(6) 2016.Patient's blood glucose (bg) at the time of the event is unknown.Patient did not report any treatment by the above mention family member other than the drive to the hospital.At the time of contact, the patient reported current condition as "better".No additional event or patient information is available.There was no alleged device malfunction.It should be noted that diabetes mellitus is a known cause of diabetic ketoacidosis.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 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: 5461373
• MDR Text Key: 39077369
• Report Number: 3004753838-2016-01278
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Public: (01)NI(241)NI(10)NI(17)NI
• 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: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Weight: 54