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 Hyperglycemia (1905)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

Applicator (b)(4) has been returned and investigated.Visual inspection has been performed on the applicator and no issues were observed.It is observed that the applicator was fired correctly.The sharp has been investigated and no issues were observed.The issue is not confirmed.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specifications.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

The caller reported a customer being unable to test using adc device due to bent needle.It was further reported that due to this issue, the customer experienced dizziness and nausea.The caller indicated that due to this issue, the customer experienced an adverse event in which they required treatment of 2 units of insulin provided by a healthcare professional.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: 15883555
• MDR Text Key: 304501809
• Report Number: 2954323-2022-43569
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2022
• 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