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

Model Number DEXCOM G6

Device Problem Difficult to Insert (1316)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

I received a new blood glucose sensor from dexcom which did not insert correctly.When looking at the sensor information on its packaging, i see dexcom sent me a sensor which has passed its expiration date.This sensor was received from dexcom the week of november 8, 2021.The expiration date on the packaging is 09-02-2021.Pn: 9500-45, lot: 7279542.(b)(6).I'm amazed a medical device company is allowed to send patients devices which are past their expiration date.This needs to be investigated.Thank you, (b)(6).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: 12835693
• MDR Text Key: 281074185
• Report Number: MW5105439
• Device Sequence Number: 1
• Product Code: MDS
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/02/2021
• Device Model Number: DEXCOM G6
• Device Catalogue Number: PN: 9500-45
• Device Lot Number: 7279542
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DAILY ADULT MULTI-VITAMIN ; HUMALOG AS NEEDED; LISINOPRIL; MEDTRONIC INSULIN PUMP ; OSTEO BIFLEX; SIMVASTATIN
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White