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

Model Number	71953-01
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported device has been returned and is currently in process of investigation.A follow-up report will be filed once 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 device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.The customer indicated this event occurred three times, this report covers 3 of 3 reports.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported a display issue with the adc device.The customer observed "frozen" display and was unable to view glucose readings.The customer became hypoglycemic and lost consciousness, requiring treatment of glucagon injection administered by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
Event or Problem Description
A customer reported a display issue with the adc device.The customer observed "frozen" display and was unable to view glucose readings.The customer became hypoglycemic and lost consciousness, requiring treatment of glucagon injection administered by a non-healthcare professional.There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
The reader (b)(6) was returned and investigated.Visual inspection has been performed and liquid contamination was observed in the usb port.The liquid contamination in the usb port would prevent the customer from charging the reader which would lead to the reader not turning on.The reader was de-cased.Visual inspection was performed and liquid contamination was observed due to liquid ingress on the pcba(printed circuit board assembly).Therefore, issue in not confirmed to use due to liquid contamination.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.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: 18584538
• Report Number: 2954323-2024-03315
• Device Sequence Number: 8492084
• Product Code: QLG
• UDI-Device Identifier: 00357599805005
• UDI-Public: 00357599805005
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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): 02/19/2024

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
• Date Returned to Manufacturer: 01/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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