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); Convulsion/Seizure (4406)

Event Date 03/19/2024

Event Type  Injury  

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 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.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.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.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 use of the abbott diabetes care (adc) device.Customer received unspecified low sensor scan results when compared to unspecified readings obtained on competitor meter.As a result, customer experienced seizure, unspecified symptom(s) of perceived "hypoglycemia", "cramps in legs and wrists", and went to the hospital.At the hospital, a healthcare professional (hcp) provided unspecified third-party treatment for a diagnosis of hyperglycemia.Additionally, the hcp performed laboratory blood glucose measurements two days after the event with unspecified results.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.The watermark was observed at the base of the tail indicating the sensor being properly inserted.Sensor state 7 with event log 11, 224 and 227] and 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.Functionality test will be performed on the sensor to verify if sensor is functioning as intended.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 an smu (source measurement unit) test with 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 all functionality test indicates that there were no issues with sensor functionality and electronics.Therefore, issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.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.Section d4 (serial number) was updated from (b)(6).All pertinent information available to abbott diabetes care has been submitted.

Event Description

A low readings issue was reported with use of the abbott diabetes care (adc) device.Customer received unspecified low sensor scan results when compared to unspecified readings obtained on competitor meter.As a result, customer experienced seizure, unspecified symptom(s) of perceived "hypoglycemia", "cramps in legs and wrists", and went to the hospital.At the hospital, a healthcare professional (hcp) provided unspecified third-party treatment for a diagnosis of hyperglycemia.Additionally, the hcp performed laboratory blood glucose measurements two days after the event with unspecified results.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 94502-7001 ; 5107495297
• MDR Report Key: 19086031
• MDR Text Key: 339876663
• Report Number: 2954323-2024-12275
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K213996
• 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: 05/16/2024

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 Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2023
• 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