MAUDE Adverse Event Report: DEXCOM, INC. T:SLIM G4 SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number 9438-05

Device Problems Use of Device Problem (1670); Invalid Sensing (2293)

Patient Problem Injury (2348)

Event Date 08/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017, that on (b)(6) 2017, the patient experienced continuous glucose monitor (cgm) inaccuracies and an adverse event.The sensor was inserted into the abdomen on (b)(6) 2017.The patient stated that they had lunch when the receiver started to vibrate, alerting them that they were near 400 mg/dl.At 1:35pm, they checked their blood glucose (bg) value and it was at 93 mg/dl.They proceeded to correct the issue with insulin and called 911 as it was indicated that they felt weird.When the paramedics arrived, they checked the patient's bg level and it was 51 mg/dl.The medical staff administered the patient with glucose gel and dextrose.The patient went to the hospital and was monitored and released at 4:45pm when their bg levels were normal.At the time of contact, the patient was in stable condition.No additional patient or event information is available.No product or data were provided for evaluation.The reported event could not be confirmed.A root cause could not be determined.It was reported that the patient made treatment decisions based off the cgm values.Dexcom labeling indicates: do not use the dexcom g4 platinum (pediatric) system for treatment decisions, such as how much insulin you should take.Always use the values from your blood glucose meter for treatment decisions.Blood glucose values may differ from sensor glucose readings.Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.

• Brand Name: T:SLIM G4 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: 6839156
• MDR Text Key: 84433427
• Report Number: 3004753838-2017-76317
• Device Sequence Number: 1
• Product Code: OYC
• UDI-Device Identifier: 10386270000047
• UDI-Public: 10386270000047
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140015
• 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: 08/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/12/2017
• Device Model Number: 9438-05
• Device Catalogue Number: STT-GL-003
• Device Lot Number: 5215614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2016
• 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: 42 YR