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 Dehydration (1807); Fatigue (1849); Hyperglycemia (1905); Dizziness (2194)

Event Date 03/10/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.At this time product has not yet been returned.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 sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle 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 customer reported a low reading with the adc device.Customer obtained a sensor scan result of 143mg/dl and was compared to 394mg/dl obtained on lab results and experienced symptoms of dizziness, lightheadedness, fast paced heartbeat, dehydration, and lethargy.Customer was unable to self-treat and had contact with a healthcare professional in the emergency room who administered saline solution through an iv and insulin by pen/injection as treatment for a diagnosis of hyperglycemia.The results when plotted on a parkes error grid, fell into the "c" zone, showing the difference in values to be clinically significant.No further information was provided.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 and no issue was observed.Data was extracted using approved software, and extraction was successful.The watermark was not observed at the base of the tail.The returned sensor was further investigated and de-cases.Performed an internal visual inspection on the sensor¿s pcba (printed circuit board assembly); no issues were observed.The returned battery voltage was measured to be within specification range.Performed an smu (source measurement unit) test 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.No malfunction or product deficiency was identified.Therefore, this issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported a low reading with the adc device.Customer obtained a sensor scan result of 143mg/dl and was compared to 394mg/dl obtained on lab results and experienced symptoms of dizziness, lightheadedness, fast paced heartbeat, dehydration, and lethargy.Customer was unable to self-treat and had contact with a healthcare professional in the emergency room who administered saline solution through an iv and insulin by pen/injection as treatment for a diagnosis of hyperglycemia.The results when plotted on a parkes error grid, fell into the "c" zone, showing the difference in values to be clinically significant.No further information was provided.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: 16746812
• MDR Text Key: 313359872
• Report Number: 2954323-2023-14705
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 30357599818006
• UDI-Public: 30357599818006
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: 72081-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2023
• 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