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

Model Number 71992-01

Device Problems Device Damaged Prior to Use (2284); Packaging Problem (3007)

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

Event Date 07/12/2021

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 manufacturing 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 opening freestyle libre 2 sensor package, she noticed that the sensor was damaged.The customer was unable to monitor glucose with sensor, and subsequently lost consciousness.The customer was treated with glucose and iv by a healthcare professional for diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that after opening freestyle libre 2 sensor package, she noticed that the sensor was damaged.The customer was unable to monitor glucose with sensor, and subsequently lost consciousness.The customer was treated with glucose and iv by a healthcare professional for diagnosis of hypoglycemia.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specifications.A tripped trend review was conducted for the reported complaint and fs libre sensor, 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.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the 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: 12281678
• MDR Text Key: 265192878
• Report Number: 2954323-2021-79010
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/12/2021

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: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 66 KG