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

Model Number 9500-27

Device Problems Device Operates Differently Than Expected (2913); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2014

Event Type  malfunction  

Event Description

Patient contacted dexcom technical support on (b)(6) 2014 to report cgm inaccuracy compared to blood glucose meter on (b)(6) 2014.Patient did not calibrate according to user guide recommendations.Patient did not report any injury or medical intervention at the time of contact with dexcom technical support.

Manufacturer Narrative

(b)(4).

• Brand Name: 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: 6340 sequence drive; san diego, CA 92121 ; 8582000200
• MDR Report Key: 4112106
• MDR Text Key: 4834416
• Report Number: 3004753838-2014-30257
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/21/2015
• Device Model Number: 9500-27
• Device Lot Number: 5165420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2014
• 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: 61 YR
• Patient Weight: 92