MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 PROFESSIONAL SYSTEM; CONTINUOUS GLUCOSE MONITOR

Model Number	9500-66
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Hello, our patient who had the dexcom g6 pro (sn (b)(6)) placed on (b)(6) 2020 returned today.He had to take sensor off as he was having low alarms signals for 6 hour after placement as we discussed on (b)(4) 2021.He checked these numbers against his bg meter and off by over 100 points.I placed sn: (b)(4) on him today, successfully paired on my clinic reader but noted "sensor error " on his phone (he did disconnect previous sensor).We placed another dexcom g6 on him and it paired immediately with clinic reader and his i-phone.At each insertion location of placement did not have any scar tissues, bruising or lipo hypertrophy.No blood noted upon insertion with all three sites.I have the sn (b)(4) transmitter and can save for you.Please address these two issues with your management.If i can receive two new dexcom g6 pro that would help our clinic supply.Thanks.
Event or Problem Description
It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.The sensor was inserted on 01-20-2021.It has been reported that there was a difference in readings of 100 points.Data was evaluated and the allegation was undetermined.The probable cause could not be determined via data.There were no reported glucose values available to search within the parkes error grid calculator.The data investigation did not find blood glucose calibration values to compare to cgm values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications.No injury or medical intervention was reported.
Additional Manufacturer Narrative
Com-(b)(4).
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Subsequent to the initial mdr, a correction is required.

• Brand Name: DEXCOM G6 PROFESSIONAL SYSTEM
• Common Device Name: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 11349952
• Report Number: 3004753838-2021-35866
• Device Sequence Number: 4117650
• Product Code: QII
• UDI-Device Identifier: 00386270001092
• UDI-Public: 00386270001092
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 9500-66
• Device Catalogue Number: STP-PR-001
• Device Lot Number: 5277032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021; 11/14/2022
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 02/19/2021; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown