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 01/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Foreign distributor contacted dexcom on patient's behalf on (b)(6) 2016, to report a detached sensor wire that occurred on (b)(6) 2016.The sensor insertion was at the arm on (b)(6) 2016.Patient's mother reports that the sensor wire was left in skin.An ultrasound and x-ray were performed on patient.The ultrasound showed there was a foreign body in the patient's arm.The x-ray image indicates a shadow that is 27, 2x0, 4mm and of high density located in the soft tissue (foreign body), probably metal.The patient required surgical intervention in order to remove the sensor wire.At the time of contact, the patient was currently under medical surveillance.No additional event or patient information is available.It was reported that the sensor was worn beyond seven days.The dexcom g4 platinum continuous glucose monitoring system states: your sensor gives you sensor glucose readings for up to seven days.The performance of a sensor has not been tested beyond seven days.It was reported that the sensor was inserted into the arm.It should be noted that the dexcom g4 platinum continuous glucose monitoring system user's guide states: sensor placement and insertion is not approved for sites other than the belly (abdomen).

• 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: 5452295
• MDR Text Key: 38731412
• Report Number: 3004753838-2016-20631
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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: 01/28/2016
• 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: 12 YR
• Patient Weight: 35