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

Model Number 71992-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Dizziness (2194); Convulsion/Seizure (4406)

Event Date 03/13/2024

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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.The device manufacturing date is unknown.The date entered in section h4 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 delivery delay with a replacement adc device was reported.The replacement device was issued due to an adhesive issue was reported with the adc sensor.The sensor prematurely detached and the customer was unable to obtain readings.As a result, customer experienced.Due to delivery delay, customer was unable to test and experienced seizure/convulsion and dizziness.The customer was able to self-treat (treatment not specified).No further treatment information was reported.There were 3 unsuccessful attempts to contact the customer for additional information.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 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18993023
• MDR Text Key: 338815301
• Report Number: 2954323-2024-10299
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791001033
• UDI-Public: (01)05021791001033(17)2025-02-28(10)KTP007839(91)71994-01
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2024
• 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