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 Headache (1880); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/08/2023

Event Type  Injury  

Event Description

An "unspecified" error message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, headache and was unable to self-treat.The customer had contact with a healthcare professional (hcp) who administered glucose tablets and orange juice for treatment of a hypoglycemia diagnosis.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and sensor kit 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

An extended investigation has been performed for the freestyle libre 2 app.The customer reported receiving a "replace sensor" error message.The reported issue was investigated and attempted to be replicated.As per the abbott diabetes care compatibility guide for the freestyle libre 2 app, the reported configuration was not compatible with the freestyle libre 2 app.The latest revision of the compatibility guide is available to the customer on the abbott diabetes care website.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An "unspecified" error message was reported with the adc device in use with sm s22 phone with an android 14 operating system with software version 2.7.5.7252 and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, headache and was unable to self-treat.The customer had contact with a healthcare professional (hcp) who administered glucose tablets and orange juice for treatment of a hypoglycemia diagnosis.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: 18462978
• MDR Text Key: 332255593
• Report Number: 2954323-2024-00682
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599800000
• UDI-Public: 00357599800000
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: Male