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

Model Number	71953-01
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A battery/no power issue was reported with the abbott diabetes care (adc) device.The customer was unable to test due to the device not powering on with button press or test strip insertion.As a result, the customer experienced symptoms loss of consciousness and was unable to self-treat, requiring treatment of glucose tablets provided by a healthcare professional.A reading of 56 mg/dl was obtained from unknown source, however it is unknown what time this reading was obtained in relation to the reported treatment.There was no report of death or permanent impairment associated with this 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.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.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.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.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
A battery/no power issue was reported with the abbott diabetes care (adc) device.The customer was unable to test due to the device not powering on with button press or test strip insertion.As a result, the customer experienced symptoms loss of consciousness and was unable to self-treat, requiring treatment of glucose tablets provided by a healthcare professional.A reading of 56 mg/dl was obtained from unknown source, however it is unknown what time this reading was obtained in relation to the reported treatment.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
A battery/no power issue was reported with the abbott diabetes care (adc) device.The customer was unable to test due to the device not powering on with button press or test strip insertion.As a result, the customer experienced symptoms loss of consciousness and was unable to self-treat, requiring treatment of glucose tablets provided by a healthcare professional.A reading of 56 mg/dl was obtained from unknown source, however it is unknown what time this reading was obtained in relation to the reported treatment.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The returned reader was investigated with retained test strips.Visual inspection was performed on returned reader and no issues were observed.Meter did not powered on with button depression, strip or usb cable insertion.Reader was connected to pc and software and reader was unable to be recognized.The reader was de-cased and internal visual inspection was performed.Liquid contamination was observed.Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.Reader log could not be downloaded or attached due to the liquid contamination present on the readers pcba was preventing the reader from powering on.Issue is not confirmed to use due to liquid contamination.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 2
• Common Device Name: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 20128753
• Report Number: 2954323-2024-33988
• Device Sequence Number: 20687305
• Product Code: QLG
• UDI-Device Identifier: 00357599805005
• UDI-Public: (01)00357599805005(10)02E052D
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/02/2026

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: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 11/28/2024; 12/11/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/29/2024; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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