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

Model Number 71994-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Loss of consciousness (2418); Cognitive Changes (2551)

Event Date 06/30/2023

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.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness, "loss of knowledge", and was unable to self-treat, requiring third-party treatment of insulin (type/dose unspecified) and "fluid replacement to correct dehydration" by a healthcare professional (hcp).There was no report of death or permanent impairment associated with this event.

Event Description

An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness, "loss of knowledge", and was unable to self-treat, requiring third-party treatment of insulin (type/dose unspecified) and "fluid replacement to correct dehydration" by a healthcare professional (hcp).There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6)has been returned and investigated.The sensor plug was properly seated, and no physical damage was observed on the returned sensor patch.Data was extracted from the returned sensor patch using approved software.The sensor was found to be in sensor state 6 (indicating abnormal termination) with a brownout reset event internally logged (event 21).Visual inspection was performed on the sensor plug and no failure modes were observed.The returned sensor was sent for further investigation and de-cased.Visual inspection was performed on the pcba (printed circuit board assembly) and no issues were observed.The battery was measured, and the results were within specification.Therefore, this issue is confirmed to brown out reset.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

This serves as a correction report.All pertinent information available to abbott diabetes care has been submitted.This is a duplicate report.The reported incident has been submitted under adc case id (b)(4).

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 libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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.

Event Description

An error message was reported with the abbott diabetes care (adc) device.Customer received a "replace sensor" message and was unable to obtain readings.As a result, customer experienced a loss of consciousness, "loss of knowledge", and was unable to self-treat, requiring third-party treatment of insulin (type/dose unspecified) and "fluid replacement to correct dehydration" by a healthcare professional (hcp).There was no report of death or permanent impairment associated with this event.

• Brand Name: LIBRE 2 SENSOR FREESTYLE
• 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: 17342826
• MDR Text Key: 319270566
• Report Number: 2954323-2023-30991
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup,Followup
• Report Date: 09/27/2023

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: 71994-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 07/19/2023; 08/22/2023; 09/25/2023
• Supplement Dates FDA Received: 07/21/2023; 09/20/2023; 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• 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