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

Model Number 71940-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned.A follow-up report will be filed if product is returned or additional information is obtained.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported experiencing an allergic skin reaction while wearing an adc freestyle libre sensor.He further that since the end of (b)(6) he noticed ¿skin irritation, burning, itching and swelling¿ at the insertion site.Customer reported that on (b)(6) 2019 he had contact with a healthcare provider and was prescribed momegalen ointment (mometasone furoate, a corticosteroid).He was also advised to take a break from using the device.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned, extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.The reported complaint is related to skin irritation and allergic reactions to the patch adhesive of the libre sensor.Dose audit and environmental monitoring reports were reviewed for issues relating to sterility of the product.The sensor component has no impact on product sterility and therefore, sensor component dhrs (device history review) were not reviewed.Sensor kit dhrs have been reviewed to assess the manufacturing process, which includes the application of the adhesive to the puck.A dhr (device history review) for the fs libre sensor kit was reviewed and showed the libre sensorkit passed all tests prior to release.Dose audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for libre sensor kits.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 review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Customer reported experiencing an allergic skin reaction while wearing an adc freestyle libre sensor.He further that since the end of january he noticed skin irritation, burning, itching and swelling at the insertion site.Customer reported that on (b)(6) 2019 he had contact with a healthcare provider and was prescribed momegalen ointment (mometasone furoate, a corticosteroid).He was also advised to take a break from using the device.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
• MDR Report Key: 8473880
• MDR Text Key: 140633679
• Report Number: 2954323-2019-02682
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 84