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

Model Number 9500-44

Device Problem Invalid Sensing (2293)

Patient Problems Fatigue (1849); Malaise (2359)

Event Date 05/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Distributor contacted dexcom on (b)(6) 2016 to report that the patient experienced continuous glucose monitoring (cgm) inaccuracies compared to blood glucose (bg) meter on (b)(6) 2016. The sensor was inserted on (b)(6) 2016. It was reported that on (b)(6) 2016, a day after sensor insertion, the patient was feeling very tired and ill. The dexcom cgm indicated that his bg was 5. 4mmol/l with a 45 degree down arrow showing. The patient then did a fingerstick and his actual bg was 2. 4mmol/l. After rectifying his glucose, the cgm was recalibrated and the patient's father continued to double check his readings regularly over the next 48 hours with fingerstick tests. The sensor regained accuracy after about 36 hours and then managed to last the full 7 day without further problems, however the accuracy was never quite what had come to be expected from dexcom.

• 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: 5790258
• MDR Text Key: 49413790
• Report Number: 3004753838-2016-26631
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P120005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/06/2017
• Device Model Number: 9500-44
• Device Catalogue Number: STS-GF-004
• Device Lot Number: 5208572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/13/2016 Patient Sequence Number: 1