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

Model Number 72081-01

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2022

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensors and sensor kit passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event is unknown.The date entered in is the date abbott diabetes care became aware of the event.N/a was selected for g4 as it is unknown if the user was using android, ios, or a reader with a fs libre 3 sensor.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported via webform an insertion issue with the adc device.The customer indicated the "sensor's needle was damaged/bent before it was properly attached to the upper arm." due to this issue, customer indicated they had difficulty applying the sensor to arm and was provided unspecified treatment by a non-healthcare professional.No further details were provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.A visual inspection was performed on the returned product.The sensor was in a fired applicator.The sensor pack was removed and sharp tip was bent.Observed damage to the sensor cap seal indicating the user has reapplied the applicator cap after removal, but before attempting to fire the applicator.This rendered the use of the sensor impossible; therefore, this issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported via webform an insertion issue with the adc device.The customer indicated the "sensor's needle was damaged/bent before it was properly attached to the upper arm." due to this issue, customer indicated they had difficulty applying the sensor to arm and was provided unspecified treatment by a non-healthcare professional.No further details were provided.There was no report of death or permanent 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: 16044684
• MDR Text Key: 306100995
• Report Number: 2954323-2022-47085
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 05/18/2023

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: 06/30/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• 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