MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

Catalog Number STR-OR-001

Device Problem No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Dysphasia (2195); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)

Event Date 12/12/2022

Event Type  Injury  

Event Description

It was reported that no audio output occurred.On (b)(6) 2022, it was reported by the patient¿s parent that the patient experienced no audio output.In the morning the patient had a seizure and her eyes rolled back in her head.She was incoherent and was unable to speak words.The parent checked the child¿s bg finger stick value and it was 28 mg/dl.Although the cgm display screen showed low, no alarms or alerts had been heard to notify the parent that the child¿s bg level was low.The sensor was removed and replaced.The parent took the child to the er but no treatment details or bg values were specified.After staying at the emergency room (er) the whole day, the patient was discharged.The event occurred the same day the sensor had been inserted which was also on (b)(6) 2022.No product or data was provided for evaluation.The allegation and a probable cause could not be determined.No additional patient or event information is available.

Manufacturer Narrative

(b)(4).Diabetes mellitus is a known cause of hypoglycemia.

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
• Type of Device: CONTINUOUS GLUCOSE MONITOR
• Manufacturer (Section D): DEXCOM, INC.; 6340 sequence dr.; san diego CA 92121
• Manufacturer Contact: ashley spoto ; 6340 sequence dr.; san diego, CA 92121 ; 8582000200
• MDR Report Key: 16153568
• MDR Text Key: 307257190
• Report Number: 3004753838-2023-011065
• Device Sequence Number: 1
• Product Code: QDK
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: DEN170088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: STR-OR-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 17 YR
• Patient Sex: Female