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

Model Number 71733-01

Device Problems Unable to Obtain Readings (1516); Application Program Problem (2880)

Patient Problem Hypoglycemia (1912)

Event Date 03/04/2024

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.The customer reported missing continuous glucose readings with the freestyle libre link application (fsll app).The abbott diabetes care (adc) product quality engineering attempted to replicate the reported issue using a cellular device not identical with the reported configuration of an iphone 7 with ios 15.8.1 along with application software version 2.10.2.7677, it was found that the configuration was not able to reproduce the complaint.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care (adc) website.As the compatibility guide is provided to the customer and the incompatible configurations were used by the customer, this complaint is not confirmed.The device manufacturing date does not apply.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 (adc) has been submitted.

Event Description

A missing continuous glucose readings issue was reported with the abbott diabetes care (adc) freestyle libre link application (app) in use with an iphone 7 with ios operating system version 15.8.1.As a result, the customer was unable to monitor glucose with sensor readings and experienced hypoglycemia with symptoms described as "eye trouble" (unspecified).The customer was unable to self-treat and was in contact with a healthcare professional (hcp) who provided glucose intravenously as treatment.No further treatment or medication was reported.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: 18934868
• MDR Text Key: 338038963
• Report Number: 2954323-2024-09245
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2024
• 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