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 Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)

Event Date 05/15/2019

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 mfg 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

Customer reported experiencing an adverse skin reaction while wearing an adc freestyle libre sensor.On approximately (b)(6) 2019, customer had to remove the sensor after 11 days of wear due to physical discomfort with symptoms described as itching, red welt and burning sensation.Customer had contact with a healthcare professional on (b)(6) 2019, and was prescribed with hydrocortisone for treatment.Based on the information provided, there was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Since 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.The dhr for the 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 adverse skin reaction while wearing an adc freestyle libre sensor.On approximately (b)(6) 2019 customer had to remove the sensor after 11 days of wear due to physical discomfort with symptoms described as itching, red welt and burning sensation.Customer had contact with a healthcare professional on (b)(6) 2019 and was prescribed with hydrocortisone for treatment.Based on the information provided, there was no report of death or permanent impairment 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: 8691996
• MDR Text Key: 147753984
• Report Number: 2954323-2019-04633
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention