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

Model Number 71938-01

Device Problem Failure to Power Up (1476)

Patient Problems Fatigue (1849); Nausea (1970); Diabetic Ketoacidosis (2364); Palpitations (2467)

Event Date 06/02/2020

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 it has been determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs libre reader and 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 date of event is unknown.The date entered in section 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 battery/no power issue was reported with the freestyle libre reader.Customer reported being unable to test due to the reader not powering on with button press or test strip insertion after it was exposed to moisture.Customer experienced symptoms described as fatigue, palpitations, and nausea and was unable to self-treat.Customer was seen at a medical facility where he was diagnosed with diabetic ketoacidosis and treated with insulin via injections.There was no report of death or permanent impairment 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: tara williamson ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644472
• MDR Report Key: 10135988
• MDR Text Key: 194604826
• Report Number: 2954323-2020-03956
• 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
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71938-01
• Device Catalogue Number: 71938-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: No
• 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: 16 YR
• Patient Weight: 65