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

Catalog Number STP-PR-001

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial reporter email address: (b)(6).

Event Description

It was reported that an inaccuracy between the continuous glucose monitor (cgm) and the blood glucose (bg) meter occurred.The sensor was inserted into the arm, which is off-label usage of the device.It has been reported that there was a difference in readings of 100 points.No data was provided for evaluation.The allegation and a probable cause could not be determined.There were no reported glucose values available to search within the parkes error grid calculator.No injury or medical intervention was reported.

• Brand Name: DEXCOM G6 PROFESSIONAL SYSTEM
• Type of Device: 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: 15514709
• MDR Text Key: 306193222
• Report Number: 3004753838-2022-181722
• Device Sequence Number: 1
• Product Code: QII
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: STP-PR-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/30/2022
• 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 Sex: Prefer Not To Disclose