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

Model Number 9500-44

Device Problem Break (1069)

Patient Problems Scarring (2061); Discomfort (2330); Foreign Body In Patient (2687)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The dexcom g4 continuous glucose monitoring system user's guide states: there is a remote chance that a sensor fragment could remain under your skin if the sensor breaks while you are wearing it.If you think a sensor has broken under your skin, contact your healthcare professional and call dexcom's technical support.

Event Description

Dexcom was made aware on (b)(6) 2017, that on (b)(6) 2017, of a detached sensor wire that was retained in the patient's skin.The sensor was inserted at the abdomen on (b)(6) 2017.The patient inserted the sensor and it hurt.Patient then removed the sensor pod and the sensor wire could not be seen.Patient could feel that the sensor wire was stuck in the abdomen.In the morning, the patient contacted her clinic.On 2017, the patient went to the hospital.On (b)(6) 2017, the sensor was removed by a doctor at a clinic.At the time of contact, patient's status is good.No further event or patient information is available.No product or data was provided for investigation.The reported event could not be confirmed.The root cause could not be determined.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the initial mdr, dexcom received additional information regarding the patient's adverse event.It was reported that upon removal of the sensor pod there was no piece of the sensor wire left in the sensor pod.The skin around the insertion area had a tall, tapering protuberance that only went down when the area was touched and the skin was more tender and harder than usual.On (b)(6) 2017, the patient had x-rays taken at the hospital.The x-ray image results showed the wire lying beneath the skin.The patient was given a referral to have the wire surgically removed at the emergency surgery department.The patient was given a local anesthetic.Initially, the doctor removed a 5cm long, thin wire like object which the patient believed to be a hair and insisted that it was not the dexcom sensor wire.Additional x-rays were taken.The x-rays confirmed that the dexcom sensor wire was still in the skin.A new anesthetic was administered to the patient.An incision about 2.5cm long and 2.5cm deep was made to remove the sensor wire.The incision was stitched back up with a double layer.At the time of additional contact, the patient still felt extremely tender deep down under the cut with mild aches.The patients also stated that there is scarring in the connective tissue and it is very hard beneath the cut.No additional event or patient information is available.

Manufacturer Narrative

(b)(4).

Event Description

A sensor was returned for evaluation.A visual inspection was performed and found that the wire is missing from the sensor pod and housing puck.The customer's complaint of a missing sensor wire was 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: 6535144
• MDR Text Key: 74119257
• Report Number: 3004753838-2017-13972
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2017
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: 5219893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2016
• 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