MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Hyperglycemia (1905); Coma (2417); Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 06/01/2023

Event Type  Injury  

Event Description

A replace sensor error message was reported with the adc device and customer was unable to obtain readings.The customer reported as "sensor had caused her in a heart attack and a seizure¿.Additionally, the customer reported experiencing loss of consciousness and coma.As a result, customer was unable to self-treat, and received unspecified healthcare professional (hcp) treatment for diagnosis of hyperglycemia.The hcp performed test and scans.No further treatment information was provided.It should be noted that patients with diabetes are more likely to experience certain risk factors, including hypertension, which can increase risk of heart attack.This increased risk occurs over time and there is no direct correlation or indication that the reported device may have caused or contributed to the reported myocardial infarction.The customer's reported hba1c of 11% (or higher) puts the customer at a high increased risk of ¿heart attack¿.There was no report of death or permanent impairment 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 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 sensor and sensor kit passed all tests prior to release.The date of event is unknown.The date entered in section b3 is to the date abbott diabetes care became aware of the event based on the report of "around 5 or 4 june 2023" prior to the date abbott diabetes care became aware of the event.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 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17342880
• MDR Text Key: 319271224
• Report Number: 2954323-2023-30998
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K193371
• 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: 07/18/2023

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: 03/31/2024
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2023
• 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