MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71992-01

Device Problem High Readings (2459)

Patient Problems Hypoglycemia (1912); Tachycardia (2095); Sweating (2444)

Event Date 08/13/2020

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 determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the libre sensor and libre sensor kits and the dhrs showed the libre sensor and libre sensor kits 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 high values with a diagonal upward trend arrow when scanning the adc freestyle libre 2 sensor.On (b)(6) 2020, the customer obtained the unspecified high glucose scan and self-treated with insulin injection (dose unknown.) the customer then experienced symptoms of hypoglycemia described as tachycardia and sweating.Hcp contact was made and the customer was provided unspecified treatment for their hypoglycemic symptoms.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LIBRE 2
• Type of Device: FLASH GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: erica frank ; 1360 south loop road; alameda, CA 94502-7001 ; 5104242454
• MDR Report Key: 10800835
• MDR Text Key: 215035940
• Report Number: 2954323-2020-09949
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 11/06/2020

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: 07/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2020
• 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