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

Model Number MT22719

Device Problem No Audible Alarm (1019)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Loss of consciousness (2418)

Event Date 04/12/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.

Event Description

Dexcom was made aware on 04/14/2017 that on (b)(6) 2017, the patient experienced no audio alert, hyperglycemia, and a loss of consciousness.Patient's father reported patient was feeling ill with stomach ache all day on (b)(6) 2017.Patient had been vomiting and most likely had not eaten, or eaten very little.Patient's father reported that the continuous glucose monitor (cgm) at 12:00 pm cgm read 150 mg/dl; at 12:00 am the cgm read 200 mg/dl; at 4:00 am the cgm read 300 mg/dl.Patient's father found patient unconscious in the hallway between 3:30 am and 4:00 am on (b)(6) 2017.Patient's father transported patient to hospital where he was placed in intensive care.At hospital, patient was treated with 10 units of insulin.Patient's blood glucose (bg) was checked and it was at 780 mg/dl.At the time of contact, being released from the hospital.Patient's father alleges a lack of audio alarm led to the adverse event.Additionally, the patient's father tested the receiver's alerts and they worked.No further event or patient information is available.No product or data was provided for investigation.The reported event could not be confirmed.The root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• 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: 6544502
• MDR Text Key: 74424085
• Report Number: 3004753838-2017-40260
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 30386270000232
• UDI-Public: (01)30386270000232(241)STR-GF-001(10)5222027
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MT22719
• Device Catalogue Number: STR-GF-001
• Device Lot Number: 5222027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-001C
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 19 YR