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

Model Number 9500-35

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Distributor contacted dexcom on (b)(6) 2016 to report on behalf of patient a detached sensor wire that occurred on (b)(6) 2016.The sensor was inserted into the abdomen on (b)(6) 2016.Nurse removed sensor wire from the patient and upon its removal, did not see the sensor wire attached to the sensor pod.Nurse thought she did something incorrectly and inserted a new sensor.On (b)(6) 2016, about one month after the first sensor insertion, the patient went into the hospital for a consultation and a nurse realized there was a mass under the patient's skin.Patient did not have any symptoms and the skin was not red or inflamed.The doctor performed an ultrasound which confirmed the wire filament placed under the skin.As of (b)(6) 2016 the sensor wire had not been removed.No additional event or patient information was provided.The patient using the device is under two years old.The dexcom g4 platinum continuous glucose monitoring system states: the dexcom g4 platinum continuous glucose monitoring (cgm) system is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes.

• 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: 5546505
• MDR Text Key: 41817567
• Report Number: 3004753838-2016-25949
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 03/09/2016

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 Expiration Date: 09/24/2016
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-005
• Device Lot Number: 5203871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2015
• 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: 20 MO
• Patient Weight: 10