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

Model Number 9438-06

Device Problem Invalid Sensing (2293)

Patient Problems Hypoglycemia (1912); Seizures (2063)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Dexcom was made aware on (b)(6) 2016, that on (b)(6) 2016, the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to the blood glucose (bg) meter and an adverse event.The sensor was inserted into the abdomen on (b)(6) 2016.Patient's mother stated that the patient had a seizure during the night and patient's mother had to administer a glucagon shot.Patient's mother indicated that the seizure was caused by the cgm inaccuracy and reported that the cgm was reading 85mg/dl compared to the bg meter which read 31mg/dl.At the time of contact, the patient was fine.Additional event or patient information is not available.No product or data was returned for evaluation.The reported event of cgm inaccuracy was not confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

A transmitter (part number stt-gf-001/serial number (b)(4)/lot number 5211703) was returned for evaluation.A visual inspection was performed and no defects were found.Functional testing was performed and no failures were detected.A pairing test was performed and the tes passed.A review of the shared data log did not find any errors related to the customer complaint.The reported event of inaccuracies was not confirmed.A root cause could not be determined.It is unknown if the returned device is the product at fault.

• 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: 6105870
• MDR Text Key: 60018210
• Report Number: 3004753838-2016-52763
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000224
• UDI-Public: (01)00386270000224(241)9438-06(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,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9438-06
• Device Catalogue Number: STT-GF-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/21/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2017
• 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): Other
• Patient Age: 14 YR
• Patient Weight: 50