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

Model Number 9500-44

Device Problem Detachment Of Device Component (1104)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on (b)(4) 2017 that on (b)(6) 2017, after attempting to insert the sensor wire, it was noticed that it had detached and was stuck in the insertion site. Additionally, the patient stated that the sensor wire issue included pain and bleeding at the insertion site. The sensor was inserted at the abdomen on (b)(6) 2017. No medical intervention was reported. No additional event or patient information is available. No product or data were provided for evaluation. The reported detached sensor wire could not be confirmed. A root cause could not be determined.

• 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: 6686361
• MDR Text Key: 79058799
• Report Number: 3004753838-2017-45243
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/12/2017
• 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