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

Model Number 71992-01

Device Problem Packaging Problem (3007)

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

Event Date 09/30/2021

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 mfg date is unknown.The date entered in is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reported that one of their adc freestyle libre 2 sensor applicators was delivered unsealed and customer was therefore unable to use it to scan their glucose.Customer experienced a loss of consciousness, requiring treatment of unspecified injection provided by a healthcare provider for the diagnosis of hypoglycemia.There was no report of death or permanent impairment 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 or lot number was not 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 completed for the fs libre sensor and reported complaint and the review did not identify any trends that would indicate any product-related issues.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.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.

Event Description

Customer reported that one of their adc freestyle libre 2 sensor applicators was delivered unsealed and customer was therefore unable to use it to scan their glucose.Customer experienced a loss of consciousness, requiring treatment of unspecified injection provided by a healthcare provider for the diagnosis of hypoglycemia.There was no report of death or permanent impairment 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: 12617392
• MDR Text Key: 275959888
• Report Number: 2954323-2021-88208
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• 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
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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