MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2 PLUS; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	78747-01
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Diaphoresis (2452)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A high glucose reading issue was reported with the abbott diabetes care (adc) device.The customer received an unspecified high glucose reading on the adc device compared to an unspecified glucose reading obtained on the built-in precision meter.The customer noted a horizontal trend arrow which indicates glucose is changing slowly (less than 1 mg/dl per minute).As a result, the customer experienced cold sweats and was unable to self-treat, requiring third-party administration of juice and dark chocolate for treatment.There was no report of death or permanent impairment associated with this event.A higher reading of 8.6 mmol/l on the adc device was compared to the built-in precision meter reading of 4.8 mmol/l on the same day of sensor wear.The results, when plotted on a parkes error grid, fall into the c zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.
Additional Manufacturer Narrative
The product has been requested back for investigation and the customer agreed to return the device.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A high glucose reading issue was reported with the abbott diabetes care (adc) device.The customer received an unspecified high glucose reading on the adc device compared to an unspecified glucose reading obtained on the built-in precision meter.The customer noted a horizontal trend arrow which indicates glucose is changing slowly (less than 1 mg/dl per minute).As a result, the customer experienced cold sweats and was unable to self-treat, requiring third-party administration of juice and dark chocolate for treatment.There was no report of death or permanent impairment associated with this event.A higher reading of 8.6 mmol/l on the adc device was compared to the built-in precision meter reading of 4.8 mmol/l on the same day of sensor wear.The results, when plotted on a parkes error grid, fall into the c zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.
Additional Manufacturer Narrative
The product has been requested back for an investigation and the customer agreed to return the device; however, at this time product has not yet been received.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.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and sensor kit was reviewed and the dhrs showed the libre sensor and sensor kit met specifications prior to release to distribution.If product is returned, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.Section d4 (primary udi number) has been updated.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2 PLUS
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 24743499
• Report Number: 2954323-2026-19672
• Device Sequence Number: 17266043
• Product Code: QBJ
• UDI-Device Identifier: 05021791006991
• UDI-Public: (01)05021791006991(17)270331(10)251108P
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K223435
• 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): 05/08/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 78747-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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