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); Unspecified Infection (1930); Pain (1994)

Event Date 09/01/2018

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 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 an infection while wearing an adc freestyle libre sensor.It was further reported that on (b)(6) 2018 customer noticed ¿pain, pus, a red ring and a hard lump¿ at the insertion site.Customer noted having contact with a healthcare provider on (b)(6)2018 and was diagnosed with an abscess.Customer was prescribed flucloxacillin and fusidic acid, (antibiotics).There was no report of death or permanent injury associated with this event.

Event Description

Customer reported experiencing an infection while wearing an adc freestyle libre sensor.It was further reported that on (b)(6) 2018 customer noticed ¿pain, pus, a red ring and a hard lump¿ at the insertion site.Customer noted having contact with a healthcare provider on (b)(6) 2018 and was diagnosed with an abscess.Customer was prescribed flucloxacillin and fusidic acid, (antibiotics).There was no report of death or permanent injury 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: 7912444
• MDR Text Key: 121846223
• Report Number: 2954323-2018-07255
• 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: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• 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: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention