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

Model Number 9500-27

Device Problem Imprecision (1307)

Patient Problems Pneumonia (2011); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, there was an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter and an adverse event.The patient reported that her husband called paramedics after seeing that the cgm was displaying 366 mg/dl and that on arrival, they tested the patient's bg and found it to be 467 mg/dl.The patient was then transported the hospital where she was admitted to the intensive care unit (icu) and it was found that the patient's bg had continued to increase to 767 mg/dl.It was noted at this point that the patient had pneumonia and that it was causing their blood sugar to rise as well as respiratory failure.The patient stated that she spent 6 days in a coma out of two weeks in the icu.In addition to the pneumonia, the patient experienced hypoxia dka, a (b)(6) infection, anemia due to bleeding into sputum and the gut, and toxic metabolic encephalopathy.The patient reported that she was currently undergoing speech therapy and continued to have residual cognitive issues.Per medical review, the inaccuracy was only related to the paramedics transporting the patient to the emergency room, where the increasing blood sugar values that lead to diabetic ketoacidosis (dka) were reported to have been caused by the combination of pneumonia and (b)(6) infections, which lead to the subsequent issues reported.At the time of contact, the patient was doing good.No product or data was provided for investigation.Confirmation of the complaint was undetermined.The probable cause could not be determined.No additional patient or event information is available.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: kipp durbin ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 8166882
• MDR Text Key: 130459370
• Report Number: 3004753838-2018-156824
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: 00386270000019
• 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: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2018
• 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: 44 YR