MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)

Event Date 04/27/2023

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 in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer experienced a allergy skin reaction while wearing an adc device and experienced redness and swelling at the sensor site.Customer had contact with a healthcare professional and was provided unspecified treated for their symptoms.Customer could not recall the specific treatment provided as they stated ¿it has been a long time.¿ there was no report of death or permanent impairment associated with this event.

Event Description

A customer experienced a allergy skin reaction while wearing an adc device and experienced redness and swelling at the sensor site.Customer had contact with a healthcare professional and was provided unspecified treated for their symptoms.Customer could not recall the specific treatment provided as they stated ¿it has been a long time.¿ there was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Additional information: section d-4 (serial number) has been updated based on the returned product.D-4 (expiration date) and h-4 (manufacturing date) have been updated.Sensor (b)(6) has been returned and investigated.Visual inspection has been performed on the returned sensor patch and no issues were observed.Visual inspection was performed on the returned adhesive and no issues were observed.The reported complaint is related to skin irritation or an allergic reaction to the patch adhesive of the freestyle libre sensor.The device history records (dhrs) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensors and sensor kit passed all tests prior to release.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.No further investigation is required.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16920971
• MDR Text Key: 315116552
• Report Number: 2954323-2023-18802
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K223435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

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 Expiration Date: 02/29/2024
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention