MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Vomiting (2144); Dizziness (2194)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, 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.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.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.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.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A low reading issue was reported with the adc device.A customer reported unspecified low sensor readings and experienced symptoms of vomiting and lightheadedness.As a result, the customer was unable to self-treat and presented to the local hospital.Upon arrival, the customer was seen by a healthcare professional (hcp) who drew blood and administered insulin (type/dose unknown) for treatment.There was no report of death or permanent injury associated with this event.A sensor reading of 95 mg/dl was compared to a built-in meter reading of 214 mg/dl, and the results when plotted on a parkes error grid and fell into the c zone showing the difference in values to be clinically significant.However, it is unknown when these readings were taken in relation to the reported event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 18495089
• MDR Text Key: 332683450
• Report Number: 2954323-2024-01371
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K223435
• 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: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2023
• 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