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); Loss of consciousness (2418)

Event Date 04/10/2024

Event Type  Injury  

Manufacturer Narrative

The product has been requested for investigation.A follow-up report will be submitted once additional information is obtained.The device mfg 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 the customer was unable to obtain readings.As a result, customer experienced a loss of consciousness.Customer was unable to self-treat and third-party treatment of "something sweet" was reported.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

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 record) for the libre sensor kit was reviewed, and the dhrs showed the libre sensor kit passed all tests prior to release.Sensor (b)(6) has been returned and investigated.No physical damage was observed on the sensor patch.Adhesive was not returned.An extended investigation was further performed.Visual inspection has been performed on the returned sensor; no issues were observed.Since adhesive was not returned, further investigation was unable to be performed.Therefore the issue is closed to no product returned.If the partial product is returned, a physical investigation will be performed and a follow up report will be submitted.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 the customer was unable to obtain readings.As a result, customer experienced a loss of consciousness.Customer was unable to self-treat and third-party treatment of "something sweet" was reported.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: 19177485
• MDR Text Key: 340998951
• Report Number: 2954323-2024-14102
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 05021791002504
• UDI-Public: (01)05021791002504(17)2025-05-31(10)KTP008105(91)71990-01
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2023
• 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