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

Model Number 9500-27

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hypoglycemia (1912); Seizures (2063); Coma (2417); Loss of consciousness (2418)

Event Date 03/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient contacted dexcom on (b)(6) 2016 to report a hypoglycemic event that occurred on (b)(6) 2016.The sensor was inserted on (b)(6) 2016.Patient stated that they had severe low blood glucose (bg) on sunday morning, (b)(6) 2016.Patient had a seizure, went into a coma and almost died.Patient's wife performed rescue breathing and gave the patient 8 glucagon tablets.The ambulance was called and patient was taken to the emergency room (er) at approximately 1:00am.Patient was given d50 via iv and hydrocodone for pain relief.Patient was released from the er the same day at 12:00pm.Patient was wearing his dexcom continuous glucose monitor (cgm) at the time of the incident.Patient stated that the dexcom (cgm) never alerted to the low bg, as it displayed that the patient was at 74-79mg/dl.Paramedics read the patient's bg at 22mg/dl.Additionally, patient also reported experiencing an inaccurate cgm value of 103mg/dl compared to bg meter value of 50mg/dl.No additional event or patient information was provided.

• Brand Name: DEXCOM G5 MOBILE 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: 5546504
• MDR Text Key: 41817674
• Report Number: 3004753838-2016-02130
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(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: 03/07/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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: 51 YR
• Patient Weight: 109