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 Erythema (1840); Itching Sensation (1943); Burning Sensation (2146)

Event Date 07/01/2018

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 of manufacture is unknown.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 reported that on an unspecified date he noticed ¿itching, redness and burns¿ at the insertion site.Customer noted that in (b)(6) 2018 he had contact with a healthcare provider who prescribed betamethasone (a corticosteroid) 0.05% ointment.No additional treatment was reported.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Device manufactured date has been updated based on returned product download.Sensor (b)(4) has been returned and investigated.Visual inspection has been performed and no issues were observed.The adhesive was returned and was intact on the mount.Extended investigation was also performed.Dose audit reports and environmental monitoring reports, including bioburden and endotoxin testing, were reviewed for the quarterly period during which this complaint unit was manufactured.No abnormalities were found, and the investigation showed all processes were effective.No product deficiency was identified.No further investigation required.

Event Description

Customer reported experiencing an allergic skin reaction while wearing an adc freestyle libre sensor.He further reported that on an unspecified date he noticed ¿itching, redness and burns¿ at the insertion site.Customer noted that in july 2018 he had contact with a healthcare provider who prescribed betamethasone (a corticosteroid) 0.05% ointment.No additional treatment was reported.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
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 8362896
• MDR Text Key: 136904541
• Report Number: 2954323-2019-01603
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 78