MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Device Alarm System (1012)

Patient Problems Fatigue (1849); Hypoglycemia (1912); Dizziness (2194); Diaphoresis (2452)

Event Date 03/03/2024

Event Type  Injury  

Event Description

An alarm issue was reported with the adc device in use with galaxy z fold 4 with android operating system version 14.The customer had signal loss and was unable to receive glucose alarms.As a result, the customer experienced being dizzy, fatigue, sappy, and sweating and was unable to self-treat.The customer was provided with juice and peanut butter cracker as treatment by a non-healthcare professional (non-hcp).No further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection was performed and no issues were observed.Data was extracted from returned sensor using approved software and sensor was found to be in state 8 (indicating abnormal termination).The product was sent for further investigation.A visual inspection was performed on the returned puck (fr4 board version) and there was no evidence of misuse or abnormalities observed.Puck data was extracted and observed to be returned in sensor state 8 (abnormal termination).A bluetooth low energy (ble) test was performed on the returned puck and it's bluetooth connection was monitored for any missing data throughout the test.Dropped packets during testing or any abnormal ble test results were observed, indicating that the returned puck did not have any defects that would cause signal/connection issues.No signal loss messages or alarms during testing were observed, indicating the puck was fully functional.No product malfunctions were observed during investigation, therefore, this issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 19021261
• MDR Text Key: 339134708
• Report Number: 2954323-2024-10907
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599818006
• UDI-Public: (01)30357599818006(17)2024-06-30(10)T60001570(91)72081-01
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention