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

Model Number 72081-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hyperglycemia (1905); Tachycardia (2095); Dizziness (2194)

Event Date 11/11/2023

Event Type  Injury  

Event Description

An adhesive issue was reported with the adc sensor.The sensor prematurely detached, and the customer was unable to obtain readings.As a result, customer experienced feeling dizzy, high heart rate, and was unable to self-treat.Customer had contact with a healthcare professional (hcp) at the hospital who obtained a laboratory result of 298 mg/dl and provided an unspecified iv as treatment for the diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.The dhrs (device history record) for the freestyle libre sensor kit was reviewed and the dhrs showed the freestyle libre sensor kit passed all tests prior to release.As it is unknown if the user was using android or ios with the fs libre 3 sensor, g4 - pma/510(k) # has been populated for ios.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.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: 18296971
• MDR Text Key: 330110548
• Report Number: 2954323-2023-53337
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212132
• 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: 12/08/2023

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?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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
• Patient Sex: Female