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

Model Number 71892-01

Device Problem Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2023

Event Type  malfunction  

Event Description

Abbott diabetes care received an mhra user report which reported the following information: an issue was reported with the adc application, in use with an iphone, in which the customer experienced a white screen and the application was no longer available in the application store for reinstallation.Adc customer service successfully contacted the customer who reported the issue has since been resolved, and did not report of any adverse event or third-party intervention required due to the reported issue.The customer did further report a "replace sensor" error message with a sensor on (b)(6) 2024, but indicated no treatment was required.Adc has identified that following the release of the freestyle librelink (fsll) application for ios, v2.10.0, on 12-jul-2023 (11 a.M.) in the united kingdom (uk), some users have experienced a situation where the application upgrade is unsuccessful, and as a result, they receive a white screen in the application user interface (ui).This will result in a period where glucose readings and alarms will not be received, and historical glucose readings will not be accessible, as the previous fsll application, v2.8.1, was no longer available to users on the apple app store.This issue was addressed in the field by adc fa1029-2023 and was resolved in the field by the release of updated fsll ios application, made available in the apple app store in the uk on 17-jul-2023.Based on the information provided, there was no report of serious injury associated with this event.

Manufacturer Narrative

This complaint was investigated.Adc has identified a software defect for the freestyle librelink application for ios, version 2.10.0, in which the application upgrade was unsuccessful.This resulted in a period where users may not have received glucose results or may not have been alerted to low or high glucose alarms.Based on the investigation, the complaint is confirmed and no further investigation activities for this individual complaint are required.This issue was addressed in the field by adc fa1029-2023.The device model number populated in section d4 is for the freestyle librelink ios application, on market in the uk.This is same/similar to us freestyle librelink/freestyle libre 2 ios application part number 71733-01/71926-01.All pertinent information available to abbott diabetes care has been submitted.

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.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 and there was no indication that the product did not meet specification.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.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

Abbott diabetes care received an mhra user report which reported the following information: an issue was reported with the adc application, in use with an iphone, in which the customer experienced a white screen and the application was no longer available in the application store for reinstallation.Adc customer service successfully contacted the customer who reported the issue has since been resolved, and did not report of any adverse event or third-party intervention required due to the reported issue.The customer did further report a "replace sensor" error message with a sensor on 23-jan-2024, but indicated no treatment was required.Adc has identified that following the release of the freestyle librelink (fsll) application for ios, v2.10.0, on 12-jul-2023 (11 a.M.) in the united kingdom (uk), some users have experienced a situation where the application upgrade is unsuccessful, and as a result, they receive a white screen in the application user interface (ui).This will result in a period where glucose readings and alarms will not be received, and historical glucose readings will not be accessible, as the previous fsll application, v2.8.1, was no longer available to users on the apple app store.This issue was addressed in the field by adc fa1029-2023 and was resolved in the field by the release of updated fsll ios application, made available in the apple app store in the uk on 17-jul-2023.Based on the information provided, there was no report of serious injury associated with this event.

• 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: 18717072
• MDR Text Key: 335534703
• Report Number: 2954323-2024-05541
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71892-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: QR908720
• Patient Sequence Number: 1