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 06/25/2018

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 device mfg date is unknown.The date entered in device mfr date is the date 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 abscess at the sensor site during his 6 day wear of an adc freestyle libre sensor.Customer further reported experiencing symptoms described as redness and pain in the upper arm, and stated the"skin underneath was nearly off".On (b)(6) 2018, customer had contact with a doctor who prescribed unacid-pd (sultamicillin) oral antibiotic for treatment.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 dhrs (device history review) for all libre sensors within expiration at the time of complaint were reviewed and showed there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Dose audit reports were reviewed and demonstrated 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.A tripped trend review was completed and there were no confirmed complaints within the trend data in this review.Therefore, there were no adverse trends that indicate any potential product related issues.If the product is returned, the case will be re-opened and a physical investigation will be performed.

Event Description

Customer reported experiencing an abscess at the sensor site during his 6 day wear of an adc freestyle libre sensor.Customer further reported experiencing symptoms described as redness and pain in the upper arm, and stated the"skin underneath was nearly off".On (b)(6) 2018, customer had contact with a doctor who prescribed unacid-pd (sultamicillin) oral antibiotic for treatment.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: 7727290
• MDR Text Key: 115261753
• Report Number: 2954323-2018-05523
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• 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: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 70