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

Model Number 71988-01

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 11/13/2022

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.There was no indication that the product did not meet specification.The device history records (dhrs) for the freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre 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 healthcare professional reported on behalf of a customer who indicated that upon opening the packaging of the adc device system, " [customer] wanted to set a new sensor and noticed that the sensor was not there." the customer did not experience any symptoms, however, was seen by a healthcare professional.No further details were provided as "hcp cannot provide any information because customer is not in the office." there was no report of death or permanent injury 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.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre sensor and libre sensor kits were reviewed and the dhrs showed the libre sensor and libre sensor kits 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.This serves as a correction report.Section h-10 was incorrectly documented in the previous initial report.

Event Description

A healthcare professional reported on behalf of a customer who indicated that upon opening the packaging of the adc device system, " [customer] wanted to set a new sensor and noticed that the sensor was not there." the customer did not experience any symptoms, however, was seen by a healthcare professional.No further details were provided as "hcp cannot provide any information because customer is not in the office." there was no report of death or permanent injury associated with this event.

• 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: 15938843
• MDR Text Key: 305043749
• Report Number: 2954323-2022-44987
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: 71988-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2022
• 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