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); Nausea (1970); Confusion/ Disorientation (2553)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An alarm issue was reported with the abbott diabetes care (adc) device with a samsung sm-m215f with android version 12 operating system.The low and high glucose alarms did not sound, and the customer was not alerted of changes in glucose level.As a result, the customer experienced tingling of the tongue, nausea, significant decrease in well-being, balance disorders and was unable to self-treat, requiring treatment with sugar dissolved in water provided by a non-healthcare (non-hcp).No further treatment was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations 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.The most probable root causes associated with this failure mode are software/data corruption or misuse.However, mitigations are in place to reduce and prevent such issues.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.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) 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.The user reported missing high or low alarms.The reported issue was investigated and attempted to replicate.The reported configuration was not compatible with the freestyle librelink app.The latest revision of the compatibility guide was 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 abbott diabetes care (adc) device with a samsung (b)(6)with android version 12 operating system and app version 2.10.1.10406.The low and high glucose alarms did not sound, and the customer was not alerted of changes in glucose level.As a result, the customer experienced tingling of the tongue, nausea, significant decrease in well-being, balance disorders and was unable to self-treat, requiring treatment with sugar dissolved in water provided by a non-healthcare (non-hcp).No further treatment was reported.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18692421
• MDR Text Key: 335185089
• Report Number: 2954323-2024-05093
• Device Sequence Number: 1
• Product Code: QLG
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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