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

Model Number 9500-44

Device Problem Component Missing (2306)

Patient Problem Erythema (1840)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Dexcom was made aware on 11/27/2017, that on (b)(6) 2017, the patient experienced a missing sensor wire and an adverse event.The sensor was inserted into the upper buttocks on (b)(6) 2017.The patient's mother stated that when she removed the sensor from the patient's body, the wire stayed under the patient's skin.It was indicated that there was redness at the sensor insertion site.An ultrasound and x-ray were performed, and it was indicated that the sensor is not under the skin.The date of intervention is unknown.At the time of contact, the patient was doing good.Additional patient or event information is not available.No product was provided for evaluation.The complaint confirmation was unable to be determined.A root cause could not be determined.

• 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: 7146655
• MDR Text Key: 95789546
• Report Number: 3004753838-2017-116743
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2017
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-001
• Device Lot Number: 5229196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• 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
• Patient Weight: 45