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

Model Number 71938-01

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 06/30/2022

Event Type  Injury  

Manufacturer Narrative

At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint and determined that there was no indication that the product did not meet specification.A valid serial number has not been provided.A tripped trend review was conducted for the reported complaint and fs libre reader no trends were identified that would indicate any product related issues.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 customer reported a delivery issue with a replacement adc device, reporting they received the wrong replacement product.The replacement device was issued as customer had reported a display backlight issue.Due to delivery delay, customer reported an adverse event in which they experienced a loss of consciousness and required unspecified treatment via iv and oral for diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

• Brand Name: LIBRE READER FREESTYLE
• 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: 15533851
• MDR Text Key: 301082627
• Report Number: 2954323-2022-36476
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71938-01
• Device Catalogue Number: 71938-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2016
• 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