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

Lot Number 5279747AND7299088 (SEE ABOVE)

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Expiration Date Error (2528); Device Markings/Labelling Problem (2911)

Patient Problem Hypoglycemia (1912)

Event Type  malfunction  

Event Description

Low blood sugar.I have reported this problem on many occasions to dexcom.The manufacturer, not the diabetes supplier, is repackaging expired sensors in new boxes and shipping them to government customers.I reported this to the oig as well in december when this last occurred.Today i opened the box to insert a new sensor.The label on the box had a lot number of 7299088 with an expiration date of 3-13-2022.The package on the inside where the sensor is had a lot number of 5279747 with an expiration date of 9-14-2021.This came to me directly from the manufacturer as i have complained about this exact same thing on at least three other occasions.As a general rule, these expired sensors are very inaccurate with incorrect readings, despite calibration.No one seems to care.As i said, i contacted medicare who said they couldn't do anything about it because its contract is with the diabetes supplies and not dexcom.This is not a diabetes supplier problem as these replacement sensors are shipped from dexcom directly.I was referred to the office of the inspector general.I filed a complaint on this same thing with oig.And still, i am getting replacement sensors that have expired and cannot be calibrated.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: 13358906
• MDR Text Key: 284623906
• Report Number: MW5106995
• 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: 01/23/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5279747AND7299088 (SEE ABOVE)
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: INSULIN; JARDIANCE; LEVOTHYROXINE; METFORMIN
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White