MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM; MDS

Model Number 9500-27

Device Problems Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2016 to report a missing sensor wire that occurred on (b)(6) 2016.The sensor was inserted on (b)(6) 2016.Patient's mother stated that she took the patient to the urgent care after removing the sensor and not seeing the sensor wire.Patient's mother did not feel anything like a splinter sticking out of the patient's skin or see anything.Patient's mother provided an update on (b)(6) 2016.Patient had an x-ray performed while at the urgent care on (b)(6) 2016 which displayed the sensor wire embedded in the muscle tissue.Patient had surgery on (b)(6) 2016.The wire was about 1 inch long.At the time of contact, the patient was fine.No additional event or patient information was provided.

Manufacturer Narrative

(b)(4).

Event Description

The sensor was returned for evaluation a visual inspection was performed and the sensor wire was missing from the sensor pod and housing puck.Due to the missing sensor wire, the sensor wire is considered detached.The reported event of a missing sensor wire was confirmed.A root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• 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: 5530713
• MDR Text Key: 41304575
• Report Number: 3004753838-2016-01953
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/22/2016
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5207497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• 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): Hospitalization; Other
• Patient Age: 7 YR
• Patient Weight: 23