MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number STS-OR-003

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2018, that on (b)(6) 2018, a needle retraction issue occurred.The sensor was inserted into the upper buttocks on (b)(6) 2018.No product was provided for evaluation.Confirmation of the problem and probable cause could not be determined.Labeling indicates: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.No additional event or patient information is available.

• Brand Name: DEXCOM G6 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: 8087145
• MDR Text Key: 127932357
• Report Number: 3004753838-2018-144722
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: 00386270000255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170031
• 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: 10/27/2018

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: STS-OR-003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2018
• Initial Date FDA Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 73