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

Model Number 71953-01

Device Problem Break (1069)

Patient Problems Hyperglycemia (1905); Blurred Vision (2137)

Event Date 08/10/2023

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.And it has been determined, that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle libre reader were reviewed, and the dhrs showed the freestyle libre reader 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

Customer reported her adc device reader was damaged, and would not power on.As a result, customer was incapable of testing.And experienced an "vision problem, heat burst, and hyperglycemia".And required treatment of hcp insulin injection for the diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

Event Description

Customer reported her adc device reader was damaged and would not power on.As a result, customer was incapable of testing and experienced an "vision problem, heat burst, and hyperglycemia" and required treatment of hcp insulin injection for the diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Reader mbga301-j4457 has been returned and investigated.Visual inspection has been performed on the reader and damage was observed due to use.Customer tried to de-case the reader.The reader was further de-cased and placed into the reader test fixture to download data.Unable to extract reader data due to power surge message on pc.Therefore, issue is not confirmed to use due to damaged reader.All pertinent information available to abbott diabetes care has been submitted.

• 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: 17585191
• MDR Text Key: 321550592
• Report Number: 2954323-2023-36784
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2022
• 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