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

Model Number 71992-01

Device Problem Product Quality Problem (1506)

Patient Problems Hyperglycemia (1905); Burning Sensation (2146); Dizziness (2194)

Event Date 04/16/2023

Event Type  Injury  

Event Description

An issue of the adc device catching on fire was reported.A customer reported that while "trying to do it's warm up thing, it did it's warm up thing and then caught fire on my arm".As a result, the customer experienced described as "burn, lightheadedness, hypoglycemia, and hyperglycemia" and was unable to self-treat.The customer was administered insulin (hemolog) and "towel on the tongue" by a non-healthcare professional for treatment.No further information was reported.There was no report of serious injury, death, or mistreatment associated with this event.

Manufacturer Narrative

The reported product is not expected to be returned as reporter indicated the device was discarded.A follow-up report will be submitted once additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device mfg date is unknown.The date entered is the date abbott diabetes care became aware of the event.Physical investigation of product is not anticipated as reporter indicated device was discarded.Extended investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of all required investigation activities.All pertinent information available to abbott diabetes care has been submitted.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and libre sensor, no trends were identified that would indicate any product related issues.In the event that unanticipated product is received, a physical investigation will be performed per adc's established processes and procedures and a follow-up report will be submitted upon completion of investigation.All pertinent information available to abbott diabetes care has been submitted.

Event Description

An issue of the adc device catching on fire was reported.A customer reported that while "trying to do it's warm up thing, it did it's warm up thing and then caught fire on my arm".As a result, the customer experienced described as "burn, lightheadedness, hypoglycemia, and hyperglycemia" and was unable to self-treat.The customer was administered insulin (hemolog) and "towel on the tongue" by a non-healthcare professional for treatment.No further information was reported.There was no report of serious injury, death, or mistreatment 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: 16904702
• MDR Text Key: 314932774
• Report Number: 2954323-2023-18293
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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: 08/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• 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
• Patient Sex: Female
• Patient Weight: 87 KG