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

Model Number 72081-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Erythema (1840); Fatigue (1849); Fever (1858); Pain (1994); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 01/03/2024

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 product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.The dhrs (device history review) for the libre sensor and sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.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

A customer reported experiencing a skin reaction while wearing the adc device.The customer took off the sensor and the insertion site was red and they experienced symptoms described as "tiredness, fever, anxious, pain, very hot at the site", and an infection.The customer self-presented at a urgent care where they were diagnosed with cellulitis and warm compresses was applied at the sensor insertion.The customer was also prescribed antibiotic for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported experiencing a skin reaction while wearing the adc device.The customer took off the sensor and the insertion site was red and they experienced symptoms described as "tiredness, fever, anxious, pain, very hot at the site", and an infection.The customer self-presented at a urgent care where they were diagnosed with cellulitis and warm compresses was applied at the sensor insertion.The customer was also prescribed antibiotic for treatment.No further information was provided.There was no report of death or permanent injury associated with this event.Addiction(b)(4).Nal information: on (b)(6) 2024, the customer contacted abbott diabetes care (adc) to report additional symptoms they experienced while wearing the adc device and specific treatments they received for the reported issue.The customer further reported experiencing symptoms described as "feeling achy", swelling, pain that radiated down to the elbow, pus oozing out, and infection at the sensor insertion site.The customer had contact with a healthcare professional on (b)(6) 24 and was diagnosed with cellulites and prescribed doxycycline for treatment.The customer further reported experiencing additional symptoms which consisted of "feeling achy", pain that radiated down to the elbow, and the presence of pus was observed.The customer attempted to self-treat by applying hot packs/compresses to sensor insertion site however, their symptoms did not improve as the pus continued to oozed out and the site was "bumpy".The customer then had a follow up contact with the hcp on (b)(6) 2024 and was prescribed bactrim (antibiotics) for treatment.The customer indicated that they were using the prescribed bactrim as treatment for the reported issue and no further information was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

This serves as a follow-up report.Section b5 and b7 have been updated based on additional information received from the customer.

• 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: 18464521
• MDR Text Key: 332313328
• Report Number: 2954323-2024-00740
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599818006
• UDI-Public: 30357599818006
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 03/27/2024
• 2 Devices were Involved in the Event: 1 2

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: 03/31/2024
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• 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