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 Hypoglycemia (1912); Dizziness (2194); Loss of consciousness (2418)

Event Date 03/09/2024

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 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

An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached and as a result the customer was unable to obtain readings and experienced dizziness and had loss of consciousness.The customer was unable to self-treat and the emergency services were called and who treated the customer with glucose.There was no report of death or permanent impairment associated with this event.

Event Description

An adhesive issue was reported with the abbott diabetes care (adc) sensor.The sensor prematurely detached and as a result the customer was unable to obtain readings and experienced dizziness and had loss of consciousness.The customer was unable to self-treat and the emergency services were called and who treated the customer with glucose.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Performed a visual inspection on the returned sensor and no physical damage was observed with the sensor patch.The adhesive was returned.A visual inspection on the returned sensor adheive revealed 25% or more of the tie layer adhesive to have failed to adhere to the puck.The tie layer adhesive acts as a double-sided tape used to secure the puck to the skin adhesive.This failure of the tie layer adhesive caused the puck to be more susceptible to outside interference and could lead to skin adhesive failure.Sensor plugs were curled, indicating that the sensor was inserted properly.A review of the device history records (dhr) showed no rework or deviations at the time of manufacture.Therefore, this issue is confirmed due to an adhesive failure.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor kit were reviewed and the dhrs showed the libre sensor kit passed all tests prior to release.In section d4 - updated sn, expiration date and udi.In section h4 - updated manufacturing number.

• 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: 19175709
• MDR Text Key: 340964464
• Report Number: 2954323-2024-14089
• 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
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• 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: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2024
• 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