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); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2015, to report a broken sensor wire that occurred on (b)(6) 2015.Sensor was inserted at the abdomen on (b)(6) 2015.Patient's mother reported that when the patient took off the sensor, the sensor wire was believed to be left in the patient's skin.During contact with dexcom, the patient removed the sensor wire and stated that it was broken in the skin.Patient's mother drove the patient to the emergency room (er).An x-ray of the abdomen was performed, and no fragments of the broken sensor wire were located under the skin.Additionally, it was reported that the transmitter was snapped into the sensor pod when the sensor was removed and no portion of the sensor wire is attached to the sensor pod.Patient's mother reported that the broken sensor wire is located 4-5 inches from the patient's belly button.Patient is not experiencing any additional discomfort at sensor insertion site.At the time of contact, patient was currently fine and resting at home.No additional event or patient information is available.No product or data was provided for investigation.The reported complaint cannot be confirmed.The root cause cannot be determined.

Manufacturer Narrative

(b)(4).

Event Description

The original mdr submitted on (b)(6) 2016, reported that the patient experienced a broken sensor wire.Patient reported that the sensor wire was detached and no portion of the sensor wire was attached to the sensor pod.No additional event or patient information is available.

• 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: 5371457
• MDR Text Key: 36196542
• Report Number: 3004753838-2016-00320
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)5205374(17)161104
• 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: 12/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2016
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: 5205374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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): Other
• Patient Age: 16 YR
• Patient Weight: 77