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

Model Number 71992-01

Device Problem Failure to Fire (2610)

Patient Problems Hypoglycemia (1912); Dizziness (2194)

Event Date 12/06/2023

Event Type  Injury  

Manufacturer Narrative

The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The customer¿s product has been requested for 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.Upon review of the device history record (dhr) for the reported serial number, (b)(6), it was determined that the device was manufactured on 18 dec 2023, however, the customer indicated the reported medical event occurred on 06 dec 2023.Therefore, it can not be confirmed if the reported serial number is indeed related to this event.Clinical data was reviewed and confirmed that freestyle libre sensor continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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

The customer reported attempting to apply an adc device and being unsuccessful due to the inserter not firing, and was unable to monitor glucose levels.The customer experienced dizziness and a blood glucose reading of 1.4 mmol/l was taken on an unspecified meter.The customer had contact with paramedics who gave the customer juice for treatment of a diagnosis of hypoglycemia.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 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18970119
• MDR Text Key: 338504835
• Report Number: 2954323-2024-09889
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 03/25/2024

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: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2024
• Initial Date FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2024
• 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