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); Burning Sensation (2146)

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.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, the case will be re-opened and a physical investigation will be performed.  all pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a skin reaction with the use of the adc freestyle libre sensor and experienced "itching under the sensor and burning - sweltering on the skin".Customer had contact with an hcp who prescribed him a nasal spray, mometasone furoate sandoz (50 mg), for treatment.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported a skin reaction with the use of the adc freestyle libre sensor and experienced "itching under the sensor and burning - sweltering on the skin".Customer had contact with an hcp who prescribed him a nasal spray, memetasone furoate sandoz (50 mg), for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Visual inspection has been performed on the returned sensor patch (serial number (b)(6)) and no issues were observed.Observed the adhesive was returned.Extended investigation has also been performed.A dhr (device history review) was reviewed and verified that the unit passed all tests prior to release.Dose audit reports and environmental monitoring reports, including bioburden and endotoxin testing, were reviewed and demonstrated that all monitoring processes continue to meet requirements.No malfunction or product deficiency was identified.

• 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: 9608018
• MDR Text Key: 175814734
• Report Number: 2954323-2020-00588
• 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: 04/02/2020

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 Model Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 59