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

Model Number 71992-01

Device Problem No Device Output (1435)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

This is an initial report. this issue does not meet reportability criteria; however, it is being reported to the fda as the complaint was received via user report.Extended investigation is pending at this time and will be performed per adc's established processes and procedures.A follow-up report will be submitted upon completion of all required investigation activities.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.2 sensors were reported (s/n's unknown) and they have been captured under this submission.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a healthcare professional reported on behalf of a customer who indicated that "two (2) sensors failed to work, one stopped working and the other stopped working also.No further information was provided.There was no report of any self or third-party medical treatment reported.Adc customer service attempted to contact the hcp 3 (three) times via email to gain additional details regarding this event, however all follow up attempts were unsuccessful.Based on the information provided, there was no report of serious injury associated with this event.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a healthcare professional reported on behalf of a customer who indicated that "two (2) sensors failed to work, one stopped working and the other stopped working also.No further information was provided.There was no report of any self or third-party medical treatment reported.Adc customer service attempted to contact the hcp 3 (three) times via email to gain additional details regarding this event, however all follow up attempts were unsuccessful.Based on the information provided, there was no report of serious injury associated with this event.

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, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.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 and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.The available tripped trend reports were reviewed for libre sensor and perception code for the last year.The review identified a tripped trend for this perception code.This tripped trend was addressed in the tracking, trending review meeting, and investigated.The investigation concluded that the tripped trend was not correlated with a product nonconformance.Trends are regularly monitored and investigated when exceeding established thresholds to evaluate for causes associated with the product.If the product is returned, a physical investigation will be performed and a follow up report submitted.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, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.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 and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.The available tripped trend reports were reviewed for libre sensor and perception code for the last year.The review identified a tripped trend for this perception code.This tripped trend was addressed in the tracking, trending review meeting, and investigated.The investigation concluded that the tripped trend was not correlated with a product nonconformance.Trends are regularly monitored and investigated when exceeding established thresholds to evaluate for causes associated with the product.If the product is returned, a physical investigation will be performed and a follow up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Abbott diabetes care received a medwatch report which reported the following information: a healthcare professional reported on behalf of a customer who indicated that "two (2) sensors failed to work, one stopped working and the other stopped working also.No further information was provided.There was no report of any self or third-party medical treatment reported.Adc customer service attempted to contact the hcp 3 (three) times via email to gain additional details regarding this event, however all follow up attempts were unsuccessful.Based on the information provided, there was no report of serious 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: 16903362
• MDR Text Key: 314918172
• Report Number: 2954323-2023-18256
• 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: Other,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2024

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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1