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

Model Number 71940-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Skin Irritation (2076); Burning Sensation (2146)

Event Date 02/20/2019

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 date of event is unknown.The date entered is the date abbott diabetes care became aware of the event.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

A customer reported experiencing an adverse skin reaction after wearing the adc freestyle libre sensor for 4 days, with symptoms of allergic reaction described as redness and "burns".The customer had contact with an hcp who prescribed unspecified cortisone and antibiotic ointment for treatment.There was no report of death or permanent impairment associated with this event.

Event Description

A customer reported experiencing an adverse skin reaction after wearing the adc freestyle libre sensor for 4 days, with symptoms of allergic reaction described as redness and "burns".The customer had contact with an hcp who prescribed unspecified cortisone and antibiotic ointment for treatment.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.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 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.

• 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: 8415016
• MDR Text Key: 138641496
• Report Number: 2954323-2019-02065
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• 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: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention