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 Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 06/20/2023

Event Type  Injury  

Event Description

A device damage issue was reported with use of the abbott diabetes care (adc) reader.Customer reported reader was "damaged from drink spilling on it" and they were unable to obtain readings or monitor glucose levels.As a result, customer experienced "shaking", "pale", "hunger", and was unable to self-treat; requiring third-party treatment of "25cl of apple juice" by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and cracked screen was observed.The readers log was downloaded and observed readings in the reader indicating that this issue is not an out of box failure.Therefore, issue is not confirmed to use due to cracked screen.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 libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A device damage issue was reported with use of the abbott diabetes care (adc) reader.Customer reported reader was "damaged from drink spilling on it" and they were unable to obtain readings or monitor glucose levels.As a result, customer experienced "shaking", "pale", "hunger", and was unable to self-treat; requiring third-party treatment of "25cl of apple juice" by a non-healthcare professional.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: 17224310
• MDR Text Key: 318079452
• Report Number: 2954323-2023-27865
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• 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: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention