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

Model Number	71951-01
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A battery/no power issue was reported with the abbott diabetes care (adc) device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion.As a result, customer had contact with a healthcare professional (hcp).The hcp replaced the customer's reader with a blood glucose testing device and provided third-party treatment of "25 novolog 70/30." there was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Additional Manufacturer Narrative
Reader (b)(6) has been returned and investigated with retained test strips.Visual inspection has been performed and no issues were observed.Reader did not turn on with button depression, strip insertion or usb cable insertion.De-cased the reader and performed visual inspection, no issues were observed.The returned battery has been measured and results were within specification.Placed returned reader into the reader printed circuit board assembly (pcba) test fixture and applied pressure to the central processing unit (cpu).The reader turned on and battery was observed to be charging.Extended investigation has been performed on the reader and determined that the central processing unit (cpu) was causing the libre reader to be unresponsive to a button press, strip insertion touchscreen activation, and/or activation of a new sensor.When the cpu was physically pressed against the reader¿s print circuit board (pcb) by placing a rubber pad between the cpu and a clamp on the test fixture (to apply pressure to the cpu), the reader powered up and passed all internal built-in self-tests, and the complaint was not observed.When the pressure was removed from the cpu, the reader would revert to their reported complaint.Since the reader worked as expected when pressure was applied to the cpu, it was determined that there was poor connection between cpu and pcb.Therefore, this issue is confirmed.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader was 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.All pertinent information available to abbott diabetes care has been.
Event or Problem Description
A battery/no power issue was reported with the abbott diabetes care (adc) device reader.Customer was unable to test due to the reader not powering on with button press or test strip insertion.As a result, customer had contact with a healthcare professional (hcp).The hcp replaced the customer's reader with a blood glucose testing device and provided third-party treatment of "25 novolog 70/30." there was no report of death or permanent impairment associated with this event.

• 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: 18353761
• Report Number: 2954323-2023-54387
• Device Sequence Number: 20563812
• Product Code: QLG
• UDI-Device Identifier: 00357599805005
• UDI-Public: 00357599805005
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 02/28/2024

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: 71951-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• 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: Male