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

Model Number 71940-01

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hyperglycemia (1905); Irritation (1941); Seizures (2063); Shaking/Tremors (2515)

Event Date 02/13/2019

Event Type  Injury  

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 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 caregiver reported the customer's adc freestyle libre sensor detached after 9 days of wear.It was further reported that on (b)(6) 2019, the customer experienced symptoms described as irritation, trembling, and seizure.Customer was seen at a healthcare center where a reading of 425 mg/dl was obtained on a hospital meter.Customer was diagnosed with hyperglycemia and injected with "6 dosages" of insulin (type unknown).There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and the reported serial number was deemed invalid.An extended investigation has been performed for the reported complaint.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.A tripped trend review was completed for the reported complaint and fs libre sensors, and there were no adverse trends that indicate any potential product-related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.

Event Description

A caregiver reported the customer's adc freestyle libre sensor detached after 9 days of wear.It was further reported that on (b)(6)19, the customer experienced symptoms described as irritation, trembling, and seizure.Customer was seen at a healthcare center where a reading of 425 mg/dl was obtained on a hospital meter.Customer was diagnosed with hyperglycemia and injected with "6 dosages" of insulin (type unknown).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: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 8437020
• MDR Text Key: 139343342
• Report Number: 2954323-2019-02319
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71940-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 73