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

Model Number 71953-01

Device Problem Data Problem (3196)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported treating herself with insulin and inputting her dosage into the logbook of the adc freestyle libre reader, however the data was missing and she was unable to determine how much she administered.The customer lost consciousness and was taken to the hospital where she was diagnosed with hyperglycemia and received short-acting insulin (dose unknown).There was no report of death or permanent injury associated with this event.

Event Description

A customer reported treating herself with insulin and inputting her dosage into the logbook of the adc freestyle libre reader, however, the data was missing and she was unable to determine how much she administered.The customer lost consciousness and was taken to the hospital where she was diagnosed with hyperglycemia and received short-acting insulin (dose unknown).There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and 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 libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product-related issues.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.

• 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
• MDR Report Key: 11298860
• MDR Text Key: 230920164
• Report Number: 2954323-2021-03311
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 89