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

Model Number 9500-35

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Patient's mother contacted dexcom on (b)(6) 2015 to report continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter that occurred on (b)(6) 2015.The sensor was inserted on (b)(6) 2015.It was reported the sensor was inserted in the arm.At the time of contact, no injury or medical intervention was reported.The device was not returned for evaluation.The receiver data log was provided by the patient.The data log was reviewed on 10/14/2015.The complaint of inaccurate cgm values was confirmed.It was also reported that the sensor was inserted in 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.Other sites have not been studied and are not approved.Use in other sites might cause sensor glucose readings to be inaccurate and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.However, a root cause for the reported inaccuracies cannot be determined.

• Brand Name: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: MDS
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence drive; san diego 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: 5358990
• MDR Text Key: 35922240
• Report Number: 3004753838-2016-30253
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2016
• Device Model Number: 9500-35
• Device Catalogue Number: STS-GL-007
• Device Lot Number: 5201525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31 MO
• Patient Weight: 16