MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

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

Patient Problems Hyperglycemia (1905); Polydipsia (2604)

Event Date 05/29/2023

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 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.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.

Event Description

A webform complaint was received in which it was reported a customer received a "scan error" message on the adc device using an unknown phone and was unable to obtain readings.As a result, customer experienced symptoms of thirst and was given an injection of insulin as treatment by their daughter.No further details were provided.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 17196271
• MDR Text Key: 317806607
• Report Number: 2954323-2023-26957
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P160030
• 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: 06/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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