MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Burning Sensation (2146)

Event Date 10/11/2019

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 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 reported experiencing a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as a red, itchy, burning skin infection.Customer had contact with a healthcare professional and received an unspecified 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 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.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.Dose audit reports were reviewed and demonstrated 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.Clinical data was reviewed and confirmed that freestyle libre sensor 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 sensors, and 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 a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as a red, itchy, burning skin infection.Customer had contact with a healthcare professional and received an unspecified antibiotic for treatment.There was no report of death or permanent injury associated with this event.

Event Description

Customer reported experiencing a skin reaction while wearing an adc freestyle libre sensor and experienced symptoms described as a red, itchy, burning skin infection.Customer had contact with a healthcare professional and received an unspecified antibiotic for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

This mdr is intended as a follow up as the customer recently returned seven sensors to adc.The received sensors are: (b)(4).At the time of the reported event, the customer was not able to indicate a specific serial number, therefore, it is unknown which, if any, of the returned sensors were actually related to the medical event.However, investigations were performed for each of the returned sensors and the investigation for each of the returned sensors is as follows: partial products were returned for each of the listed serial numbers.The returned parts for each sensor serial number were the sensor patch, puck, and plug.Visual inspections were performed on the returned parts for each sensor serial number and no issues were observed.Dhrs (device history review) for the freestyle libre sensor kit were reviewed for each serial number and the dhrs showed the freestyle libre sensor kits passed all tests prior to release.Dose audit reports were reviewed for each sensor serial number and demonstrates the continued effectiveness of the established sterilization process for libre sensor products.Environmental monitoring reports were reviewed for each sensor serial number, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.There was no indication that the product did not meet specification.If the applicators and sharps are returned, the case will be re-opened, and further physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 9351193
• MDR Text Key: 167325218
• Report Number: 2954323-2019-09149
• 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: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 01/17/2020; 05/28/2020
• Supplement Dates FDA Received: 02/12/2020; 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 94