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

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hypoglycemia (1912); Chills (2191); Loss of consciousness (2418)

Event Date 06/18/2022

Event Type  Injury  

Event Description

A nurse reported a "check sensor" error with the adc device.The customer was unable to obtain sensor readings became cold and lost consciousness.A neighbor treated customer with glucagon injection, and the nurse then treated customer with food.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is properly seated and no physical damage was observed on the sensor patch.Extracted data from returned sensor using approved software.Sensor found to be in state 1 (storage state) and insertion failures were not observed in the event log.Visual inspection has been performed on the sensor plug assembly, no failure modes were observed.This complaint is not confirmed due to use as there was no insertion failures, which is the evidence that user did not activate the sensor.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A nurse reported a "check sensor" error with the adc device.The customer was unable to obtain sensor readings became cold and lost consciousness.A neighbor treated customer with glucagon injection, and the nurse then treated customer with food.There was no report of death or permanent injury associated with this event.

Event Description

A nurse reported a "check sensor" error with the adc device.The customer was unable to obtain sensor readings became cold and lost consciousness.A neighbor treated customer with glucagon injection, and the nurse then treated customer with food.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has 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 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.The sensor was successfully scanned using a similar configuration (freestyle librelink special edition app and a5x device) and was not able to replicate the complaint.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 14877326
• MDR Text Key: 295068189
• Report Number: 2954323-2022-21938
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2022

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 Expiration Date: 07/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/13/2022; 07/19/2022
• Supplement Dates FDA Received: 07/18/2022; 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2022
• 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