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); Discomfort (2330); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 04/26/2023

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 manufacturing 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

A webform complaint was received in which it was reported a customer received a "check sensor" message on the adc device and was unable to obtain readings.As a result, customer experienced discomfort and a seizure and/or loss of consciousness.Customer was treated with sweet flavored milk by a third-party (sister).There was no report of death or permanent impairment associated with this event.

Event Description

A webform complaint was received in which it was reported a customer received a "check sensor" message on the adc device and was unable to obtain readings.As a result, customer experienced discomfort and a seizure and/or loss of consciousness.Customer was treated with sweet flavored milk by a third-party (sister).There was no report of death or permanent impairment 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 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.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.Sensor found to be in state 1 (storage state) and insertion failures were observed in the event log.Visual inspection was performed on plug assembly and use related damage was observed on sensor tail.Sensor was activated with known good reader.Therefore, this issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A webform complaint was received in which it was reported a customer received a "check sensor" message on the adc device and was unable to obtain readings.As a result, customer experienced discomfort and a seizure and/or loss of consciousness.Customer was treated with sweet flavored milk by a third-party (sister).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: 16868401
• MDR Text Key: 314553776
• Report Number: 2954323-2023-17145
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/07/2023

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 Expiration Date: 04/30/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 06/04/2023
• Supplement Dates FDA Received: 05/15/2023; 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2022
• 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