MAUDE Adverse Event Report: ABBOTT DIABETES CARE LTD FREESTYLE LIBRE 3; CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number 72081-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Nausea (1970); Vomiting (2144); Diabetic Ketoacidosis (2364)

Event Date 04/30/2023

Event Type  Injury  

Manufacturer Narrative

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 and stability were reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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

A low readings issue was reported with the adc device.Customer received a sensor scan result of 60 mg/dl and experienced symptoms described vomiting, nausea, polyuria, and ketoacidosis.Customer was unable to self-treat and was admitted into the intensive care unit of a hospital where a reading of 884 mg/dl was obtained on an unspecified hospital device and insulin therapy (dose/type unspecified) was administered for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Sensor (b)(6) has been returned and investigated.Visual inspection performed on the returned sensor patch and no issue was observed.Data was extracted using approved software and extraction was successful.Sensor state 8 with event log 9 are an indication that the sensor had terminated due to an error recognized by the sensor.This is a part of software design and is not an indication of product non-conformance.Smu (source measurement unit) test will be performed on the sensor to verify if sensor is functioning as intended.A watermark did not observed at the base of the tail.The returned sensor was further investigated and de-cased.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.Performed smu (source measurement unit) test using connector key to ensure the sensor's electronics were functioning correctly and the returned unit did not have any glucose reading issues.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.The passing of functionality testing is an indication that there were no issues with sensor functionality and electronics.Therefore, issue is not confirmed.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs 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.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 a sensor scan result of 60 mg/dl and experienced symptoms described vomiting, nausea, polyuria, and ketoacidosis.Customer was unable to self-treat and was admitted into the intensive care unit of a hospital where a reading of 884 mg/dl was obtained on an unspecified hospital device and insulin therapy (dose/type unspecified) was administered for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

• Brand Name: FREESTYLE LIBRE 3
• Type of Device: CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE LTD; range road; witney 12345 -700; UK 12345-7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 16986933
• MDR Text Key: 315794415
• Report Number: 2954323-2023-21094
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K223435
• 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: 01/24/2024

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 Expiration Date: 12/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/23/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization