MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE

Model Number 9500-45

Device Problems Device Markings/Labelling Problem (2911); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2021

Event Type  malfunction  

Event Description

On wednesday, (b)(6) 2021, i opened a box containing a single dexcom g6 sensor.The product inside was expired (exp.9-10-2021 lot# 7279769).The box it came in was labelled completely differently (exp.9-03-2022 lot# 7298986).The box was a replacement single dexcom g6 sensor box that i received directly from dexcom.I called dexcom to inform them of the issue.The representative mentioned that they sometimes test expired products and if it meets certain conditions, they give it an extended expiration and then send them out.The representative also said that he will be sending me two replacement sensors and to throw away the expired one which i was calling about.I did not throw it away; i still have the product if you need to see it.Even if it is true that the product may have met certain conditions, why repackage that product with different information and lot number? from what i understand this is a misbranding issue and potentially illegal.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 13177508
• MDR Text Key: 283486769
• Report Number: MW5106493
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/10/2021
• Device Model Number: 9500-45
• Device Lot Number: 7279769
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; COQ-10; DEXCOM G6 SYSTEM; LEVEMIR FLEXTOUCH; LISINOPRIL ; MULTIVITAMIN ; NOVOLOG FLEXPEN; SOTALOL; VITAMIN D ; XARELTO ; ZINC
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White