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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

The reported product is not expected to be returned as the device was reportedly discarded.A follow-up report will be submitted if product is returned or additional information is obtained.The date the incident occurred is unknown.The date entered is the date abbott diabetes care became aware of the event.The device manufacturing 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 customer reported a signal loss alarm issue with the freestyle libre 2 sensor, and as a result the low glucose alarm failed to trigger.The customer experienced shaking, and sweating.The customer was unable to self-treat, and was given glucose.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

No product has 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, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.Section h4 (device manufacturing date) was updated based on the extended investigation.

Event Description

A customer reported a signal loss alarm issue with the freestyle libre 2 sensor, and as a result, the low glucose alarm failed to trigger.The customer experienced shaking and sweating.The customer was unable to self-treat and was given glucose.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: 11095778
• MDR Text Key: 224388917
• Report Number: 2954323-2020-14649
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 60