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

Model Number 71953-01

Device Problem Premature Discharge of Battery (1057)

Patient Problem Hyperglycemia (1905)

Event Date 01/25/2024

Event Type  Injury  

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and a damaged usb port was observed.Visual inspection was performed on the returned usb/charging cable and no issues were observed.Successful testing was performed on the returned charging cable.A visual inspection was also performed on the power adapter and no issues were observed.The current of the power adapter was measured and the voltage was within specification, and therefore it passed testing.The reader was sent for further investigation and was de-cased.The reader was placed in a text fixture to download log, however it was unsuccessful.Therefore, the issue is not confirmed due to a use.An extended investigation has also been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history record) for the libre reader and kit pack for verification of correct cable and adapter were reviewed and the dhrs showed the libre reader passed all tests prior to release and the correct cable and adapter were part of the kit pack.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a fast-draining battery issue with the adc device.The customer had no symptoms, however, required an insulin injection (dose/type unknown) administered by the healthcare professional for treatment.No further treatment was required.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: 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: 18777420
• MDR Text Key: 336202004
• Report Number: 2954323-2024-06681
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female