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

Model Number 72081-01

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Nausea (1970)

Event Date 09/11/2023

Event Type  Injury  

Event Description

A delivery delay with a replacement abbott diabetes care (adc) device was reported.The replacement device was issued due to an unspecified "sensor message" message displaying and customer was unable to test.Due to delivery delay, customer experienced "nausea", was unable to self-treat, and had contact with a healthcare professional (hcp).The hcp provided third-part treatment of intravenous "fluids" and insulin (type/dose unspecified) for a diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.

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 and it has been determined that there was no indication that the product did not meet specification.The device history records (dhrs) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor 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.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: 18190658
• MDR Text Key: 328782080
• Report Number: 2954323-2023-51008
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599819003
• UDI-Public: 30357599819003
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• 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?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2023
• 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