MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71732-01

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 01/18/2023

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 mfg date is unknown.The date entered in device manufacture date 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 adc device.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced hypoglycemia blood sugar levels below 50 mg/dl, shaking hands, sweating and difficulty speaking.Customer was unable to self-treat, requiring treatment of four fudge candies by third-party.Customer received unspecified treatment from hcp for diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Event Description

An alarm issue was reported with the adc device in use with phone model bv9900 pro blackview, operating system version 9 and app version 2829318.The low and high glucose alarms did not sound and customer was not alerted of changes in glucose level.As a result, the customer experienced hypoglycemia blood sugar levels below 50 mg/dl, shaking hands, sweating and difficulty speaking.Customer was unable to self-treat, requiring treatment of four fudge candies by third-party.Customer received unspecified treatment from hcp for diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

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 functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.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.Extended investigation has been performed and the freestyle librelink complaint was investigated and determined that there were no issues with the librelink application that would have led to the complaint.The user reported missing high and low glucose alarm notifications with their sensor.Attempted to replicate the user¿s complaint using similar configuration and successfully received high and low glucose readings and alarm notifications in the application.The user complaint could not be reproduced.Therefore, this complaint is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: DATA MANAGEMENT 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: 16297713
• MDR Text Key: 308784819
• Report Number: 2954323-2023-05431
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P160030
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71732-01
• Device Catalogue Number: 71732-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• 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