MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number	72081-01
Medical Device Problem Codes	Device Alarm System (1012); Computer Operating System Problem (2898); Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: the customer reported receiving an unexpected low glucose alarm on the adc device.They indicated that they attempted to lower the alarm threshold in the application from 70 mg/dl to 60 mg/dl to prevent the alert: however, the low glucose alarm still triggered at 69 mg/dl.The customer also noted that the alarm event was not recorded in the logbook and that disabling the low glucose alarm feature did not resolve the issue.Adc customer service successfully contacted the customer, who later confirmed that they resolved the issue through their own troubleshooting and required no further assistance.There was no report of any third-party treatment.Based on the information provided, there was no report of serious injury associated with this event.
Additional Manufacturer Narrative
This complaint was received via user report and has been reported to fda.An investigation is pending at this time.A follow up will be submitted once all investigation activities are completed or additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The operating system is unknown so the d4 - model # and primary udi number populated is for ios.The operating system is unknown so the g4 - pma/510(k) # populated is for ios.All pertinent information available to abbott diabetes care has been submitted.
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 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.A valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The available tracking and trending reports were conducted for the reported complaint and fs libre reader, no trends were identified that would indicate any product related issues.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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: the customer reported receiving an unexpected low glucose alarm on the adc device.They indicated that they attempted to lower the alarm threshold in the application from 70 mg/dl to 60 mg/dl to prevent the alert; however, the low glucose alarm still triggered at 69 mg/dl.The customer also noted that the alarm event was not recorded in the logbook and that disabling the low glucose alarm feature did not resolve the issue.Adc customer service successfully contacted the customer, who later confirmed that they resolved the issue through their own troubleshooting and required no further assistance.There was no report of any third-party treatment.Based on the information provided, there was no report of serious injury associated with this event.
Additional Manufacturer Narrative
The product has been requested back for an investigation and the customer agreed to return the device.However, no product has been received at this time despite follow up attempts by adc.He 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.A valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and the product; no trends were identified that would indicate any product related issues.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.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: the customer reported receiving an unexpected low glucose alarm on the adc device.They indicated that they attempted to lower the alarm threshold in the application from 70 mg/dl to 60 mg/dl to prevent the alert; however, the low glucose alarm still triggered at 69 mg/dl.The customer also noted that the alarm event was not recorded in the logbook and that disabling the low glucose alarm feature did not resolve the issue.Adc customer service successfully contacted the customer, who later confirmed that they resolved the issue through their own troubleshooting and required no further assistance.There was no report of any third-party treatment.Based on the information provided, there was no report of serious injury associated with this event.
Event or Problem Description
Abbott diabetes care (adc) received a medwatch report which reported the following information: the customer reported receiving an unexpected low glucose alarm on the adc device.They indicated that they attempted to lower the alarm threshold in the application from 70 mg/dl to 60 mg/dl to prevent the alert; however, the low glucose alarm still triggered at 69 mg/dl.The customer also noted that the alarm event was not recorded in the logbook and that disabling the low glucose alarm feature did not resolve the issue.Adc customer service successfully contacted the customer, who later confirmed that they resolved the issue through their own troubleshooting and required no further assistance.There was no report of any third-party treatment.Based on the information provided, there was no report of serious injury associated with this event.
Additional Manufacturer Narrative
The product has been requested back for an investigation and the customer agreed to return the device.However, no product has been received at this time despite follow up attempts by adc.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.A valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and the product; no trends were identified that would indicate any product related issues.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.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 3
• Common Device Name: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 24228023
• Report Number: 2954323-2026-06869
• Device Sequence Number: 10230058
• Product Code: QLG
• UDI-Device Identifier: 00357599817008
• UDI-Public: 00357599817008
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K212132
• 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,Followup,Followup
• Report Date (Section B): 05/26/2026

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 Model Number: 72081-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/06/2026; 03/20/2026; 04/29/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/06/2026; 04/14/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 138 KG