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)

Event Date 08/28/2018

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 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

Customer's father reported his daughter experienced an allergic skin reaction after 14 days of wearing an adc freestyle libre sensor.Customer noticed bruising and abscess at the sensor site after removal of the sensor and had contact with a healthcare professional who prescribed fucidin cream (fusidic acid) and pyostacine cream (pristinamycin) - topical antibiotics for treatment.There was no report of death or permanent injury associated with this event.

Event Description

Customer's father reported his daughter experienced an allergic skin reaction after 14 days of wearing an adc freestyle libre sensor.Customer noticed bruising and abscess at the sensor site after removal of the sensor and had contact with a healthcare professional who prescribed fucidin cream (fusidic acid) and protacine cream (pristinamycin) - topical antibiotics for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dhrs (device history record) 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 products.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.If the product is returned, a physical investigation will be performed, and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

No product has been returned and a valid sensor serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for all libre sensors and libre sensor kits within expiration at the time of complaint were reviewed, and the dhr review showed no there were no deviations from the validated manufacturing process and no issues identified that could have led to the complaint.  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.Clinical data was reviewed and confirmed that fs libre sensors continue to be safe, effective, and perform as intended in the field.A tripped trend review was completed for the reported complaint and fs libre sensor, there were no confirmed complaints.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's father reported his daughter experienced an allergic skin reaction after 14 days of wearing an adc freestyle libre sensor.Customer noticed bruising and abscess at the sensor site after removal of the sensor and had contact with a healthcare professional who prescribed fucidin cream (fusidic acid) and pyostacine cream (pristinamycin) - topical antibiotics 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: 7908331
• MDR Text Key: 121699828
• Report Number: 2954323-2018-07206
• 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,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 50