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

Model Number 72079-01

Device Problem No Device Output (1435)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that the adc device did not start after the blood sample was applied to the test strip and as a result, the customer was unable to monitor their blood glucose.The customer experienced a symptom of "high ketones" and was seen at a hospital where unspecified treatment was provided for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

Event Description

A customer reported that the adc device did not start after the blood sample was applied to the test strip and as a result, the customer was unable to monitor their blood glucose.The customer experienced a symptom of "high ketones" and was seen at a hospital where unspecified treatment was provided for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

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 dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and damage was observed on the reader due to use related issue.Therefore, issue is not confirmed to use.Section h4 (device mfg date) was updated based on returned product download.Section d4 (serial number) was updated from (b)(6).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: 17786608
• MDR Text Key: 323890622
• Report Number: 2954323-2023-41518
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K223435
• 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: 02/02/2024

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: 72079-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention