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

Model Number 71953-01

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/17/2020

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 it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader 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 that the adc freestyle libre 2 reader would not power on with button press or test strip insertion.As a result, the customer was unable to monitor their glucose levels and experienced unspecified symptoms of hypoglycemia, and subsequently lost consciousness.The customer was treated with "emergency syringe and cola" by his wife.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that the adc freestyle libre 2 reader would not power on with button press or test strip insertion.As a result, the customer was unable to monitor their glucose levels and experienced unspecified symptoms of hypoglycemia, and subsequently lost consciousness.The customer was treated with "emergency syringe and cola" by his wife.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader ((b)(6) ) has been returned and investigated with retained test trips.Visual inspection was performed on the returned reader and damage to the usb port was observed.The reader did not power on with button depression, strip insertion, or insertion of usb cable.The damaged usb port prevented the customer from charging the reader which led to the customer observing a blank screen.The issue is not confirmed to a user issue.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.Additional information- sections d-3 (email) and g1: (contact office first name, contact office last name, contact office phone number, and contact office email) have been updated.

• 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
• MDR Report Key: 11067231
• MDR Text Key: 223469659
• Report Number: 2954323-2020-14365
• 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,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 95