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

Model Number 71992-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 02/08/2023

Event Type  Death  

Manufacturer Narrative

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 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.The product has been requested back for an investigation.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 freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.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

Abbott diabetes care (adc) received a complaint from a caregiver who reported the death of her husband, who was using the adc device at the time of death.The caregiver reported that the sensor gave "inaccurate readings", and a glucose value in the range of 13 to 20 mmol/l was obtained based on which customer self-treated with 16 units of insulin.Following the treatment, emergency services were called, and customer was transported to a hospital where a laboratory reading of 69.5 mmol/l was obtained.It was reported that customer suffered damage to his organs and was admitted to the "special care unit" for 4 days.Customer passed away on (b)(6) 2023.No further information was provided.Attempts have been made to contact the reporter, and thus-far been unsuccessful.There was no official cause of death reported.Given the information presented at this time, it is inconclusive that the freestyle libre 2 device has led to or contributed to the death of the patient.A follow up will be sent if further information is obtained.

Event Description

Abbott diabetes care (adc) received a complaint from a caregiver who reported the death of her husband, who was using the adc device at the time of death.The caregiver reported that the sensor gave "inaccurate readings", and a glucose value in the range of 13 to 20 mmol/l was obtained based on which customer self-treated with 16 units of insulin.Following the treatment, emergency services were called, and customer was transported to a hospital where a laboratory reading of 69.5 mmol/l was obtained.It was reported that customer suffered damage to his organs and was admitted to the "special care unit" for 4 days.Customer passed away on (b)(6) 2023.No further information was provided.Attempts have been made to contact the reporter, and thus-far been unsuccessful.There was no official cause of death reported.A follow up will be sent if further information is obtained.Abbott diabetes care (adc) was able to obtain the following additional information on 20 nov 2023, from the reporter (customer's spouse): it was reported that the customer was initially hospitalized, beginning on (b)(6) 2023, where the previously reported laboratory glucose result of 69.5 mmol/l was obtained.The customer was diagnosed with diabetic ketoacidosis (dka) and unspecified treatment was provided to decrease blood glucose levels.Details regarding further treatment, diagnoses, or health conditions addressed over the duration of the hospitalization were not provided.It was reported by the spouse that the official cause of death was a heart attack, but the reporter stated that the autopsy report was not available as they had not yet received one.No further details are available at this time.It remains inconclusive at this time that the freestyle libre 2 device has led to or contributed to the death of the patient.A follow-up report will be submitted if additional information is obtained.

Manufacturer Narrative

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 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 for the sensor 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.The device history records (dhrs) for the freestyle libre reader were reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.Clinical data was reviewed and confirmed that freestyle libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for freestyle libre sensors was reviewed and showed no anomalies or non-conformances that could have led to the complaint.A tripped trend review was conducted for the reported complaint and freestyle libre sensors, no trends were identified that would indicate any product related issues.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.Upon follow up contact with the reporter, they indicated that the sensor in question was no longer in their possession, but provided the freestyle libre 2 reader serial number (b)(6) and stated that it was available for return.If the freestyle libre 2 reader in question 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.

• 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: 18062873
• MDR Text Key: 327238714
• Report Number: 2954323-2023-48406
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/29/2023

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?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death