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

Model Number 71992-01

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

Patient Problems Purulent Discharge (1812); Erythema (1840); Pain (1994); Skin Infection (4544)

Event Date 03/23/2023

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 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

An adverse skin reaction was reported while wearing the adc device.The customer experienced symptoms described as oozing, redness, pain, suppuration and skin infection at the sensor site.The customer further reported having contact with an healthcare professional who provided unspecified antibiotic cream for treatment.There was no report of death or permanent injury associated with this event.

Event Description

An adverse skin reaction was reported while wearing the adc device.The customer experienced symptoms described as oozing, redness, pain, suppuration and skin infection at the sensor site.The customer further reported having contact with an healthcare professional who provided unspecified antibiotic cream for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and 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.Dhrs (device history review) 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.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.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.No physical damage was observed on the sensor patch.No issues were observed with adhesive.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.  all pertinent information available to abbott diabetes care has been submitted.

Event Description

An adverse skin reaction was reported while wearing the adc device.The customer experienced symptoms described as oozing, redness, pain, suppuration and skin infection at the sensor site.The customer further reported having contact with an healthcare professional who provided unspecified antibiotic cream for treatment.There was no report of death or permanent injury 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 CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16671866
• MDR Text Key: 312595921
• Report Number: 2954323-2023-13342
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 05/12/2023

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 Expiration Date: 12/31/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 04/04/2023; 04/22/2023
• Supplement Dates FDA Received: 04/19/2023; 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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