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

Model Number 9500-27

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

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 reported that he did not visualized the sensor wire at the skin side of the sensor pod.Patient went to urgent care on (b)(6) 2017 where the sensor wire was removed from the skin with tweezers.At the time of contact, patient is a little sore on abdomen.No additional patient or event information was provided.No product or data was provided for investigation.The reported event could not be confirmed.The root cause could not be determined.

• Brand Name: DEXCOM G5 MOBILE CONTINUOUS 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: 6327072
• MDR Text Key: 67286917
• Report Number: 3004753838-2017-10837
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000019
• UDI-Public: (01)00386270000019(241)5209875(10)NI(17)170223
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2017
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-041
• Device Lot Number: 5209875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• 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: 26 YR
• Patient Weight: 84