MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigation's are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The customer¿s product has been requested for investigation.At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.The customer experienced signal loss.The reported issue was unable to be replicated as the reported configuration of [xiaomi redmi note 10 pro] is not compatible with the freestyle librelink app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the adc device in use with an xiaomi redmi note 10 pro phone with android 11 operating system.Customer experienced a signal loss and was unable to receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hypoglycemia symptoms and a loss of consciousness.Customer was however unable to self-treat with a glucagon injection provided by a non-healthcare provider for treatment.There was no report of death or permanent impairment associated with this event.

Event Description

An alarm issue was reported with the adc device in use with an xiaomi redmi note 10 pro phone with android 11 operating system and app version 2.10.1.10406.Customer experienced a signal loss and was unable to receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced hypoglycemia symptoms and a loss of consciousness.Customer was however unable to self-treat with a glucagon injection provided by a non-healthcare provider for treatment.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the sensor patch.The sensor was found to be in state 5 (indicating normal termination).Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.The sensor was activated with a known good reader and the bluetooth connection was successful.A linearity test was performed while the reader was wrapped in aluminum foil (to simulate signal loss), and signal loss message was observed.Since the sensor and known good reader communicated successfully, and a signal loss message was observed after simulating a signal loss, the returned sensor was found to be functioning properly.The sensor was scanned with reader to re-establish ble connection and then placed 20ft (6.1m) from the sensor, and no signal loss message was displayed.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 19000706
• MDR Text Key: 338874355
• Report Number: 2954323-2024-10420
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791002504
• UDI-Public: (01)05021791002504(17)2025-04-30(10)KTP008024(91)71990-01
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K193371
• 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,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2023
• 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