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

Model Number 9500-35

Device Problem Break (1069)

Patient Problems Erythema (1840); Foreign Body In Patient (2687)

Event Date 03/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The g5 system is associated with product code pqf.The dexcom g5 mobile continuous glucose monitoring system user's guide states: on rare occasions, the sensor wire may break or detach from the sensor pod.If a sensor wire breaks under the skin with no portion of it visible, don't remove it.Contact your healthcare professional if you have redness, swelling, or pain at the insertion site.

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, of a broken sensor wire.The sensor was inserted at the abdomen on (b)(6) 2017.Patient reported seeing "most" of the sensor wire at the underside of the sensor pod.Patient thinks part of sensor wire is still under the skin.Patient does not know if all of the sensor wire was removed.Affected area was treated with antibiotics and topical cortisone prescribed on (b)(6) 2017.The name of the antibiotics is unknown.Patient is a u.S.Patient with u.S.Device, and the event occurred while he was in australia.No additional event or patient information is available.No product or data was provided for investigation.The reported issue could not be confirmed.The root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE 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: 6436163
• MDR Text Key: 70968816
• Report Number: 3004753838-2017-13916
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/05/2017
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-005
• Device Lot Number: 5215231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• 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): Other
• Patient Age: 35 YR