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

Model Number	71733-01
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The customer experienced incompatible device/operating system with the use of freestyle librelink application.Smartphone compatibility with the use of freestyle librelink and the iphone 16 version 18.4.1 has not been tested at the time of the investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.This guide is available to the user on the websites where the product is launched.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 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 united kingdom 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 or Problem Description
A customer previously contacted abbott diabetes care (adc) to report that their freestyle librelink application in use with iphone 16 with ios operating system and version 18.4.1 would not scan the sensors.Upon troubleshooting, it was determined that the customer was using an incompatible operating system and an order for a reader was placed for the customer.However, the customer reported that there was a delivery delay with the reader and they had no way to monitor their glucose.The customer was unable to test and experienced loss of consciousness due to hypoglycemic event and was unable to self-treat.A non-healthcare professional provided them with glucogel as treatment.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
A customer previously contacted abbott diabetes care (adc) to report that their freestyle librelink application in use with iphone 16 with ios operating system and version 18.4.1 and app version 2.12.0.8319 would not scan the sensors.Upon troubleshooting, it was determined that the customer was using an incompatible operating system and an order for a reader was placed for the customer.However, the customer reported that there was a delivery delay with the reader and they had no way to monitor their glucose.The customer was unable to test and experienced loss of consciousness due to hypoglycemic event, and was unable to self-treat.A non-healthcare professional provided them with glucogel as treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The user reported incompatible device.The reported issue was investigated.The reported configuration was not compatible with the customer's reported application.The latest revision of the compatibility guide was available to the customer on the abbott diabetes care website.As the compatibility guide is provided to the customer and the incompatible configurations were used, this complaint is not confirmed to use.This serves as a correction report.Section h11(additional mfg narrative) was incorrectly updated in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRELINK
• Common Device Name: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda 94502-7001 ; 4157205405
• MDR Report Key: 22071361
• Report Number: 2954323-2025-18589
• Device Sequence Number: 8702009
• Product Code: PZE
• UDI-Device Identifier: 00357599000059
• UDI-Public: 00357599000059
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P160030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown