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

Model Number 71733-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

Patient Problems Fatigue (1849); Hypoglycemia (1912)

Event Date 03/03/2024

Event Type  Injury  

Manufacturer Narrative

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.Freestyle librelink complaint was investigated and no issues with the librelink application in use with a reported configuration iphone 8, ios 16.3.1, 2.10.2.7677 is not compatible with the freestyle librelink applicationwas determined that would have led to the complaint.The user reported signal loss alarm with the freestyle librelink application.Attempted to replicate the issue using similar device configuration and was not able to reproduce the complaint as it was not compatible with the freestyle librelink app.The device manufacturing date does not apply.The date entered in section h4 is the date abbott diabetes care became aware of the event.Section d.Suspected medical device and g4 - pma/510(k)# has been populated for the freestyle librelink ios application as this report concerns a polish customer.This is same/similar to us freestyle libre 2 ios application, model number 71926-01.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 iphone with ios operating system version 15.8.Customer experienced a signal loss and was unable to obtain readings and receive glucose alarms.As a result, customer was not alerted of changes in glucose level and experienced weakness and was unable to self-treat, requiring treatment of cola and a meal (unspecified) by third-party.There was no report of death or permanent impairment 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 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18950871
• MDR Text Key: 338256033
• Report Number: 2954323-2024-09560
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention