MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

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

Patient Problems Abscess (1690); Erythema (1840); Pain (1994); Skin Infection (4544); Swelling/ Edema (4577)

Event Date 08/27/2022

Event Type  Injury  

Manufacturer Narrative

Sensor (b)(4) has been returned and is currently undergoing investigation process.A follow up report will be submitted once all investigation activities are complete.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.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 customer reported a skin reaction at the site of the adc device.The customer reported symptoms of pain, redness, and swelling.The customer went to hospital and mri was done to confirm abscess.The customer was treated with antibiotics via iv drip and hospitalized for 8 days.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.No physical damage observed on sensor patch and no issues were observed with the adhesive.No malfunction or product deficiency was identified.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history record) for the freestyle libre sensor and freestyle libre sensor kit were reviewed, and the dhrs showed the freestyle libre sensor and freestyle libre 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.All pertinent information available to abbott diabetes care has been submitted.Per additional information received from customer, the following sections have been updated: b3 - date of event.B5 - describe event or problem.

Event Description

A customer reported a skin reaction at the site of the adc device.The customer reported symptoms of pain, redness, and swelling.The customer went to hospital and mri was done to confirm abscess.The customer was treated with antibiotics via iv drip and hospitalized for 8 days.The following additional information is being provided in this report: on 07 nov 2022 the customer provided the discharge report from hospital, for the reported skin reaction at the site of the adc device.The discharge report provided the following new information: on 27 aug 2022, the customer presented to emergency department with pain and swelling at the site of the sensor and a self-reported fever of 39.2 c.A soft-tissue ultrasound was performed and the customer was prescribed oral augmentin (amoxicillin and clavulanate antibiotic) and sent home.Per the customer, the pain and swelling increased and they presented back to hospital on (b)(6) 2022.At this time the customer was admitted to hospital with progressive cellulitis.All vitals were found to be normal upon physical examination, and it was noted that the customer's arm was red, swollen, and hot.A doppler ultrasound was performed and there was no evidence of dvt (deep vein thrombosis).Final diagnosis of customer's condition was progressive, non-purulent cellulitis.The customer was treated with ceftriaxone 2g via iv, daily, and clindamycin 600 mg/dl via iv every 8 hours.The customer was discharged on (b)(6) 2022 (4 days hospitalization, non-icu) and prescribed a 10 day course of clindamycin 300 mg (oral) to be taken every 8 hours.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 15584612
• MDR Text Key: 301546891
• Report Number: 2954323-2022-37477
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P160030
• 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: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention