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

Model Number 9500-44

Device Problem Invalid Sensing (2293)

Patient Problems Dehydration (1807); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 07/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of diabetic ketoacidosis.

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.It was reported that during the night, the patient was feeling sick and vomiting.A new sensor was inserted that night and when the initial calibration was needed to be done around 12:00am, the patient calibrated twice with the cgm reading of 150 mg/dl.During the night, the cgm remained at 150 mg/dl until the patient's aunt measured their blood glucose that read 560 mg/dl.The ambulance was called and the patient was brought to the hospital presenting with severe diabetic ketoacidosis, was unresponsive and dehydrated.The patient was treated with an insulin intravenous (iv), liquid and potassium.It was indicated that the patient calibrated a lower bg than what was displayed on the bg meter.At the time of contact, the patient was still in the hospital but was in good condition.No additional patient 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.The patient entered incorrect bg values.Labeling indicates: to calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement.Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, dexcom received additional information on (b)(4) 2017.A doctor's report was provided, which stated that the patient was taken to the intensive care unit (icu) at the time of the event.On the second day in the hospital, the patient slowly cleared up and their blood glucose and ketones normalized and was able to discontinue intravenous (iv) potassium.On the third day in the hospital, the patient was moved from the icu to a normal station.On (b)(6).The patient was released from the hospital and was in good condition.Additionally, the doctor's report stated that on (b)(6) the patient entered the values of 156mg/dl and 166mg/dl into the dexcom continuous glucose monitor (cgm).The patient's blood glucose was measured at 524mg/dl and 533mg/dl.It was indicated that the cgm was falsely calibrated and indicated that the patient had normal blood glucose values.It was known to the patient that the cgm could be manipulated in that way and the patient calibrated wrongly twice in the past.It was reported that the patient would now calibrate under the supervision of her parents.Additional event or patient information is not available.

• Brand Name: DEXCOM G4 PLATINUM 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: 6774604
• MDR Text Key: 82070296
• Report Number: 3004753838-2017-50428
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/18/2018
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: 5225155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2017
• 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: 12 YR
• Patient Weight: 61