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

Model Number 9500-27

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 09/15/2016, that on (b)(6) 2014, the patient experienced a detached sensor wire.Date of issue is an approximation.The sensor was inserted into the upper buttocks.Patient's mother reported that the retained sensor was inserted in the back of the child and resulted in local abscess.About 6 weeks after the event, the wire emerged together with scab tissue and was removed by a nurse practitioner.Removal occurred on (b)(6) 2014.Additional event or patient information was not provided.No product or data was returned for a device evaluation.The reported event of detached sensor wire could not be confirmed.A root cause could not be determined.

Manufacturer Narrative

(b)(4).

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE 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: 6032083
• MDR Text Key: 57550804
• Report Number: 3004753838-2016-80646
• 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,Followup
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2016
• 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: 10/14/2016
• 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): Other
• Patient Age: 4 YR