MAUDE Adverse Event Report: DEXCOM INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Catalog Number 9445-24

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hypoglycemia (1912)

Event Date 08/05/2021

Event Type  Injury  

Event Description

Dexcom g6 sensor producing false and incorrect readings putting patient life at risk.Patient has replaced sensor four times in the last week.Company has been contacted with no satisfactory results.Keep replacing sensor but to no avail.Have tried different lot numbers with adverse glucose readings.When sensor reading is compared to finger stick reading there is a discrepancy > 20%.The following number has been called several times, (b)(6).Only solution has been a new sensor; however, reliability issues continued threatening patient's life.Called on monday (b)(6), sensor replaced lot number 7290435/ pn 9500-45, # 5937 additional faulty sensor tag # 5931, transmitter 9445-24 / sn (b)(4) activated on (b)(6) 2021.This malfunction translated into incorrect/adverse insulin adjustment and excessive carbohydrate intake precipitated by low glucose readings and corresponding false repetitive alarms.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 12324905
• MDR Text Key: 267042863
• Report Number: MW5103250
• Device Sequence Number: 1
• Product Code: QBJ
• UDI-Device Identifier: 00386270000255
• UDI-Public: 0100386270000255
• 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: 08/11/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 9445-24
• Device Lot Number: 7290435
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR