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

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 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pediatric nurse practitioner contacted dexcom on (b)(6) 2016 to report on behalf of trial patient a detached sensor wire that occurred on (b)(6) 2016.Trial patient was at the clinic to have a new sensor placed and upon removal of the old sensor, the sensor wire was no longer attached to the sensor pod and remained partially imbedded in the patient's arm.Nurse pulled out the sensor wire from the patient's skin.Sensor wire was removed without incident and was intact.No injury or medical intervention was reported.The sensor was inserted into the arm.The dexcom g4 platinum (pediatric) continuous glucose monitoring system user's guide states: do not insert the sensor in sites other than the belly (abdomen) or upper buttocks.

• 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: 5543014
• MDR Text Key: 41717670
• Report Number: 3004753838-2016-06564
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 03/04/2016
• 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 Age: 11 YR