MAUDE Adverse Event Report: Abbott Diabetes Care Inc FreeStyle Libre 2; Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

Model Number	71992-01
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A low readings issue with the abbott diabetes care (adc) device was reported.The customer received an unspecified low scan on the adc device.It is unknown whether the customer noted a trend arrow on the device.The customer was asymptomatic and was unable to self-treat.The customer had contact with healthcare professional (hcp) who obtained blood glucose result of 381 mg/dl and required administration of insulin injection (dose/type unknown) for the diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
A low readings issue with the abbott diabetes care (adc) device was reported.The customer received an unspecified low scan on the adc device.It is unknown whether the customer noted a trend arrow on the device.The customer was asymptomatic and was unable to self-treat.The customer had contact with healthcare professional (hcp) who obtained blood glucose result of 381 mg/dl and required administration of insulin injection (dose/type unknown) for the diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Physical investigation of product is not anticipated as reporter indicated device was discarded.Investigation will be performed per adc's established processes and procedures, and a report will be submitted upon completion of investigation activities.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
The reported product is not expected to be returned as reporter indicated the device was discarded.Therefore, no further investigation is planned.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.This also serves as a correction report.D4 - expiration date was incorrectly documented in the previous report.Correction has been made.At this time, the product has not yet been returned for this complaint.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.In the event that product is received, a physical investigation will be performed per adc's established processes and procedures and a report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FreeStyle Libre 2
• Common Device Name: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
• Manufacturer (Section D): Abbott Diabetes Care Inc; 1360 south loop road; alameda CA 94502 -700
• Manufacturer Contact: melissa pieplow ; 1360 south loop road; alameda, CA 94502--700 ; +1(510)384-5975
• MDR Report Key: 50483199
• Report Number: 2954323-2026-297084
• Device Sequence Number: 10234210
• Product Code: QLG
• UDI-Device Identifier: 00357599836016
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K193371
• 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): 09/24/2026

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 Expiration Date: 07/31/2026
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2025
• 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 Age: 73 YR
• Patient Sex: Female