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

Model Number 71992-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 07/23/2022

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 device mfg date is unknown.The date entered 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 after pressing on the adc sensor application to ensure a secure placement, the customer began bleeding.The customer experienced feeling dizzy, lightheaded, and eventually lost consciousness while drinking water at the table.After regaining consciousness, the customer noticed a bruise at the sensor site.Customer service (cs) advised the customer to consult with their doctor regarding this event.No medication or additional treatment was required.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that after pressing on the adc sensor application to ensure a secure placement, the customer began bleeding.The customer experienced feeling dizzy, lightheaded, and eventually lost consciousness while drinking water at the table.After regaining consciousness, the customer noticed a bruise at the sensor site.Customer service (cs) advised the customer to consult with their doctor regarding this event.No medication or additional treatment was required.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: section h4 (device mfg date) has been updated based on extended investigation.Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history record) for the libre sensor and sensor kit were reviewed and the dhrs showed the libre sensor and sensor kit passed all tests prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report as the initial mdr was inadvertently missing the extended investigation on the reported sensor.H6 (adverse event problem) and h10 (addtl mfg narrative) have been updated to include extended investigation findings.

• 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: 15262257
• MDR Text Key: 298260416
• Report Number: 2954323-2022-30073
• 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,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other