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

Model Number 71992-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Fainting (1847); Hypoglycemia (1912); Loss of consciousness (2418)

Event Date 12/06/2020

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 sensor and libre sensor kits were reviewed 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 an error message when scanning the adc freestyle libre 2 sensor and as a result, there was no scanned value, and low glucose alarm was not triggered.On (b)(6) 2020, the customer fainted and lost consciousness and was brought to the emergency room where a lab glucose of 2.4 mmol/l was obtained and the customer was diagnosed with hypoglycemia.The customer was given an infusion of sodium chloride and other unknown treatments.Additional lab tests of 5.8 mmol/ l and 7.4 mmol/l were also obtained and no further treatment was required.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Sensor (b)(6) was returned and investigated.No physical damage observed on the sensor patch.Observed sensor plug was not seated properly in mount (indicating improper assembly by the user).Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Therefore, this issue is not confirmed to use as the sensor plug was not properly seated.All pertinent information available to abbott diabetes care has been submitted.Additional information- section g1: (contact office first name, contact office last name, contact office phone number and contact office email) have been updated from (b)(6) to (b)(6).

Event Description

A customer reported an error message when scanning the adc freestyle libre 2 sensor and as a result, there was no scanned value, and low glucose alarm was not triggered.On (b)(6)2020, the customer fainted and lost consciousness and was brought to the emergency room where a lab glucose of 2.4 mmol/l was obtained and the customer was diagnosed with hypoglycemia.The customer was given an infusion of sodium chloride and other unknown treatments.Additional lab tests of 5.8 mmol/ l and 7.4 mmol/l were also obtained and no further treatment was required.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
• MDR Report Key: 11009104
• MDR Text Key: 221465134
• Report Number: 2954323-2020-13364
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 76