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

Model Number 71992-01

Device Problem Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 03/03/2022

Event Type  Injury  

Event Description

A bent inserter needle was reported with the use of the adc device.A caller reported that the sensor tip was bent and experienced pain at the insertion site and received unknown third-party medical treatment for the reported issue.No further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kit were reviewed and the dhrs showed the libre sensor and libre sensor kits passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Sensor (b)(6) was returned and inspected and no issues were observed.The sensor plug is fully seated.Inspected the plug assembly.Visual inspection was performed and cracked sensor neck was observed.Sensor state 5 is an indication of normal sensor termination and full wear by the user, therefore the cracked sensor neck observed during investigation occurred post-wear.This issue likely occurred due to the movement of the used sensor during shipment back to adc for investigation.If the applicator and sensor pack is returned a physical investigation will be performed and a follow up report will be submitted.Hence, issue is closed to no product returned.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A bent inserter needle was reported with the use of the adc device.A caller reported that the sensor tip was bent and experienced pain at the insertion site and received unknown third-party medical treatment for the reported issue.No further information was provided.There was no report of death or permanent injury 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: 13826800
• MDR Text Key: 287524903
• Report Number: 2954323-2022-08920
• 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,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female