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

Model Number 71702-01

Device Problem Insufficient Information (3190)

Patient Problem Palpitations (2467)

Event Date 07/17/2018

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 health care professional reported that a customer experienced heart palpitations that coincided with the initial wear of an adc freestyle libre sensor on (b)(6) 2018.The patient removed the sensor on (b)(6) 2018 after 2 days of wear and visited the hcp on (b)(6) 2018.The hcp prescribed valium (diazepam) for treatment.There was no report of death or permanent injury associated with this event.

Event Description

A health care professional reported that a customer experienced heart palpitations that coincided with the initial wear of an adc freestyle libre sensor on (b)(6) 2018.The patient removed the sensor on (b)(6) 2018 after 2 days of wear and visited the hcp on (b)(6) 2018.The hcp prescribed valium (diazepam) for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has been returned and a valid serial number has not been provided.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 all fs libre sensor kits within expiration at the time of complaint were reviewed, and the dhr review showed no there were no deviations from the validated manufacturing process.A tripped trend review was completed for the reported complaint and fs libre sensor, no trips were observed.If the product is returned, the case will be re-opened and a physical investigation will be performed.

• Brand Name: FREESTYLE LIBRE
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 7821009
• MDR Text Key: 118386804
• Report Number: 2954323-2018-06408
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71702-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR