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

Model Number MT22495

Device Problem No Audible Alarm (1019)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Coma (2417); Loss of consciousness (2418)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(6) 2016 that on (b)(6) 2016, the patient experienced no audio alert and an adverse event.Date of event is an approximate.Patient reports that the continuous glucose monitor (cgm) did not alert for a rapid rise and for blood glucose (bg) level over 400 mg/dl.Patient asserts that this lead to the adverse event.Patient reported that patient's husband discovered the patient had collapsed at home.Patient's husband called an ambulance.By the time emergency medical technicians (emts) arrived, patient was conscious and vomiting blood.Patient's husband reported that the cgm was displaying the high, but was not making an alert.Patient was transported to hospital.Patient reported losing consciousness and went into coma for nine (9) days.When the patient woke up, she was sent home.Patient was treated with an iv drip at home.Additionally, the patient tested the alert function of the receiver and the audio alert did work, but it did not vibrate.At time of contact, patient is recovering at home.No additional event or patient information is available.No product or data was provided for investigation.The reported issue could not be confirmed.The root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

The complaint device was returned for evaluation.The device was externally visually inspected and no defect was found.A review of the downloaded data log did not find any issues related to the customer complaint.Functional testing was performed and the audio test failed.The receiver case was opened for further evaluation.A visual interior inspection was performed and the inspection failed.A speaker resistance test was performed and confirmed the reported event of no audio output.The root cause was determined to be a defective speaker assembly.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE 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: 6381616
• MDR Text Key: 69173436
• Report Number: 3004753838-2017-18742
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 30386270000157
• UDI-Public: (01)30386270000157(241)STR-DR-001(10)5215281(15)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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MT22495
• Device Catalogue Number: STR-DR-001
• Device Lot Number: 5215281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3004753838-02/29/16-00
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 43 YR
• Patient Weight: 66