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

Model Number 9500-27

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). The g5 system is associated with product code pqf.

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. Patient's mother reported that this was her first insertion. The sensor felt normal after insertion. Then the sensor failed to pair or calibrate. Patient's mother could not see any portion of the sensor wire above the patient's skin. Patient's mother palpated the insertion area and she felt something was there. She also reported visually seeing a blood clot at the insertion area. Patient has not been seen by a clinician. There was no reported sign of infection. At the time of contact, patient is okay. 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. The transmitter was removed prior to removing the sensor pod. Labeling indicates: do not remove the transmitter before removing the sensor pod from your body.

• 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: 6538148
• Report Number: 3004753838-2017-35670
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)9500-27(10)NI(17)NI
• 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

• Type of Report: Initial
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• 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: 04/04/2017
• 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
• Patient Weight: 45
• Patient Outcome(s): Other