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

Model Number 71702-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Skin Irritation (2076)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The actual date when the event occurred in unknown.The date listed is the date when abbott diabetes care became aware of the event.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 allergic skin reactions, with ¿redness¿ and an abscess while wearing an adc freestyle libre sensor.It was further reported the issues began in (b)(6) 2018, starting with a ¿mild rash¿, but now the sites bleed when the sensor is removed.She noted having contact with multiple healthcare providers, who prescribed/advised her to pre-treat with unspecified corticosteroids, apply tincture of benzoin and spray unspecified antihistamines on the skin at the insertion site.When none of these treatments worked, she was advised to discontinue using the device.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and a valid serial number was not provided.Extended investigation has been performed for the reported complaint and 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.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 components dhrs were not reviewed.Sensor kit dhrs have been reviewed to assess the manufacturing process, which includes the application of the adhesive to the puck.Dhrs (device history review) for all fs libre sensor kits within expiration at the time of complaint were reviewed, and the dhr review showed no there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint dose audit reports were reviewed and demonstrates 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.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and there were no confirmed complaints within the trend data in this review.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Customer reported experiencing allergic skin reactions, with ¿redness¿ and an abscess while wearing an adc freestyle libre sensor.It was further reported the issues began in (b)(6) 2018 starting with a ¿mild rash¿, but now the sites bleed when the sensor is removed.She noted having contact with multiple healthcare providers, who prescribed/advised her to pre-treat with unspecified corticosteroids, apply tincture of benzoin and spray unspecified antihistamines on the skin at the insertion site.When none of these treatments worked, she was advised to discontinue using the device.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE
• 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: 7850348
• MDR Text Key: 119344629
• Report Number: 2954323-2018-06685
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 62