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

Model Number 71953-01

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 12/13/2021

Event Type  Injury  

Event Description

A customer reported being unable to test glucose using the adc freestyle libre 2 reader due to the reader not powering on.As a result, the customer required third-party treatment.However, treatment details were not provided as the customer refused to provide further information and disconnected the call.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported product is not expected to be returned as the device was reportedly discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the freestyle libre reader was reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13154975
• MDR Text Key: 283174061
• Report Number: 2954323-2022-00125
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• 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: 01/04/2022

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
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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: Male