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

Model Number 71953-01

Device Problem Data Problem (3196)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 11/05/2022

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 date of event is unknown.The date entered is based on the customer's report of "first saturday of november".The device manufacturing date is unknown.The date entered 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 settings/memory issue was reported with the adc device and customer experienced a seizure, a loss of consciousness and was unable to self-treat.Customer had contact with a healthcare professional provided something to put on the nose as treatment for the diagnosis of hypoglycemia.In addition, on (b)(6) 2022, customer had contact with a healthcare professional (doctor) to "try to fix the sounds".No further information was provided.There was no report of death or permanent impairment associated with this event.

Event Description

A settings/memory issue was reported with the adc device and customer experienced a seizure, a loss of consciousness and was unable to self-treat.Customer had contact with a healthcare professional provided something to put on the nose as treatment for the diagnosis of hypoglycemia.In addition, on (b)(6) 2023, customer had contact with a healthcare professional (doctor) to "try to fix the sounds".No further information was provided.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.Reader (b)(6) was returned and investigated.Visual inspection have been performed on the returned reader and no issues were observed.The audio and vibration functions were tested.Both audio and vibration functions worked properly.Therefore, this issue is not confirmed.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: 16093024
• MDR Text Key: 306588745
• Report Number: 2954323-2023-00256
• Device Sequence Number: 1
• Product Code: QLG
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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 Age: 72 YR
• Patient Sex: Female