MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71940-01

Device Problem Low Readings (2460)

Patient Problems Hyperglycemia (1905); Dizziness (2194); Discomfort (2330); Polydipsia (2604)

Event Date 10/28/2021

Event Type  Injury  

Manufacturer Narrative

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.Dhrs (device history record) 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 reading issue was reported with the freestyle libre sensor.The customer obtained low sensor scans and experienced symptoms of discomfort, thirst, dizziness and was taken to the hospital.A blood glucose result of 460 mg/dl was obtained from the healthcare meter and customer received 6 units of novorapid insulin for treatment of hyperglycemia.There was no report of death or permanent injury associated with this 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.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A low reading issue was reported with the freestyle libre sensor.The customer obtained low sensor scans and experienced symptoms of discomfort, thirst, dizziness and was taken to the hospital.A blood glucose result of 460 mg/dl was obtained from the healthcare meter and customer received (b)(4) units of novorapid insulin for treatment of hyperglycemia.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 14 DAY
• 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: 12783765
• MDR Text Key: 280570085
• Report Number: 2954323-2021-91748
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P160030
• 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: 05/31/2022

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: 05/31/2022
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 05/29/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2021
• 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
• Patient Sex: Male
• Patient Weight: 86 KG