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

Model Number 71992-01

Device Problem Device Alarm System (1012)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418); Sweating (2444)

Event Date 11/01/2020

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

Customer's freestyle libre 2 sensor did not alarm for low glucose and because of this, the customer experienced hypoglycemia with sweating and a loss of consciousness.Customer was incapable of self-treating and was administered a glucagon injection by her husband.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 for the libre reader.An extended investigation has been performed for the reported complaint, and there was no indication that the product did not meet specifications.A tripped trend review was conducted for the reported complaint and libre reader; no trends were identified that would indicate any product-related issues.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.

Event Description

Customer's freestyle libre 2 sensor did not alarm for low glucose and because of this, the customer experienced hypoglycemia with sweating and a loss of consciousness.Customer was incapable of self-treating and was administered a glucagon injection by her husband.There was no report of death or permanent injury associated with this event.

• Brand Name: LIBRE 2 SENSOR FREESTYLE
• 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: 10862666
• MDR Text Key: 216950866
• Report Number: 2954323-2020-11179
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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