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 Inflammation (1932); Infection, Pyrogenic (2246)

Event Date 11/23/2017

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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported experiencing a "ball that kept growing" at the insertion site of the adc freestyle libre sensor.Customer removed the sensor after 5 days of wear and had contact with a healthcare professional on (b)(6).Customer further reported the "ball" was not painful unless touched and was "full of blood and pus and measured to be 10 cm by 7 cm by the nurses".Doctors stated it was not an allergic reaction and prescribed an unspecified cream that was to be applied for 10 days.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned.Extended investigation has been performed for the reported complaint an it has been 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 was reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Those audit reports were reviewed and demonstrated the continued effectiveness of the established sterilization process for freestyle 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.

Event Description

Customer reported experiencing a "ball that kept growing" at the insertion site of the adc freestyle libre sensor.Customer removed the sensor after 5 days of wear and had contact with a healthcare professional on (b)(6).Customer further reported the "ball" was not painful unless touched and was "full of blood and pus and measured to be 10cm by 7cm by the nurses".Doctors stated it was not an allergic reaction and prescribed an unspecified cream that was to be applied for 10 days.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: 7155200
• MDR Text Key: 96061728
• Report Number: 2954323-2017-09210
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• 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: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2017
• 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 Weight: 120