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 Fatigue (1849); Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Polydipsia (2604)

Event Date 08/13/2023

Event Type  Injury  

Event Description

A low readings issue was reported with the adc device.Customer received lower sensor scan result of 109 and 110 mg/dl compared to readings obtained on a hcp meter of 500 and 269 mg/dl and experienced symptoms of "increased thirst, fatigue and difficulty in balance".The customer was unable to self-treat.Customer self presented to the emergency room and was seen by a healthcare professional and was treated with intravenous fluids for hydration and insulin through insulin pump for a diagnosis of diabetic ketoacidosis.No further information was provided.There was no report of death or permanent injury associated with this event.Sensor results of 109 and 110 mg/dl was compared to a laboratory blood glucose results of 500 and 269 mg/dl and the results, when plotted on a parkes error grid and fell into the "d" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.

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 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.

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, mitigation's 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.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.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

A low readings issue was reported with the adc device.Customer received lower sensor scan result of 109 and 110 mg/dl compared to readings obtained on a hcp meter of 500 and 269 mg/dl and experienced symptoms of "increased thirst, fatigue and difficulty in balance".The customer was unable to self-treat.Customer self presented to the emergency room and was seen by a healthcare professional and was treated with intravenous fluids for hydration and insulin through insulin pump for a diagnosis of diabetic ketoacidosis.No further information was provided.There was no report of death or permanent injury associated with this event.Sensor results of 109 and 110 mg/dl was compared to a laboratory blood glucose results of 500 and 269 mg/dl and the results, when plotted on a parkes error grid and fell into the "d" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A low readings issue was reported with the adc device.Customer received lower sensor scan result of 109 and 110 mg/dl compared to readings obtained on a hcp meter of 500 and 269 mg/dl and experienced symptoms of "increased thirst, fatigue and difficulty in balance".The customer was unable to self-treat.Customer self presented to the emergency room and was seen by a healthcare professional and was treated with intravenous fluids for hydration and insulin through insulin pump for a diagnosis of diabetic ketoacidosis.No further information was provided.There was no report of death or permanent injury associated with this event.Sensor results of 109 and 110 mg/dl was compared to a laboratory blood glucose results of 500 and 269 mg/dl and the results, when plotted on a parkes error grid and fell into the "d" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse 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: 17615896
• MDR Text Key: 321876838
• Report Number: 2954323-2023-37327
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2023
• 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