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

Model Number 9500-27

Device Problem Detachment Of Device Component (1104)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient contacted dexcom on (b)(6) 2016 to report a detached sensor wire that occurred on (b)(6) 2016.The sensor was inserted on (b)(6) 2016.On (b)(6) 2016, the patient went to urgent care to address the sensor wire dislodging under the skin upon its insertion, which was causing pain.The patient was discharged the same day, after examination.On the same night, (b)(6) 2016, the patient went to the emergency room to address pain being caused by the dislodged sensor wire.The patient was discharged that night after being prescribed norco and ibuprofen for pain-management with an appointment for an ultrasound scheduled for (b)(6) 2016.The ultrasound was performed on (b)(6) 2016 and upon the results, the decision was made to leave the sensor wire in the skin and to monitor for further issues or complications.At the time of contact, the patient was at home and recovering.No additional event or patient information was provided.

• Brand Name: DEXCOM G4 PLATINUM 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: 5544618
• MDR Text Key: 41764687
• Report Number: 3004753838-2016-02128
• 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: Other
• Type of Report: Initial
• Report Date: 03/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9500-27
• Device Catalogue Number: STS-GL-011
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 21 YR
• Patient Weight: 59