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

Model Number 72081-01

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problems Bruise/Contusion (1754); Erythema (1840)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.This complaint was received via user report and has been reported to fda.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.The operating system is unknown so product information provided is for ios.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: packaging difficulty of use was reported with use of the abbott diabetes care (adc) device as customer was "unable to unscrew the cap from the sensor." as a result, customer experienced "hands red and raw from trying to unscrew the cap"; no third-party treatment/medication reported.No contact information was provided to adc, therefore adc is unable to attempt any follow up activities related to this event.Based on the information provided, there was no report of serious injury associated with this event.

• 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: 18813839
• MDR Text Key: 336616217
• Report Number: 2954323-2024-07275
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213132
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/29/2024

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: 72081-01
• Device Lot Number: T60001548
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1