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 Fall (1848); Hypoglycemia (1912); Chills (2191); Discomfort (2330); Loss of consciousness (2418)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow-up report submitted.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

A high readings issue was reported with use of the adc freestyle libre 2 sensor.Customer received an unspecified high sensor scan result and experienced "discomfort, fall due to loss of consciousness, heat flashes with chills, jerky breathing".Customer was helped by her son to get up and have a glass of water and no further treatment was provided.There was no report of death or permanent impairment 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: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13428163
• MDR Text Key: 284959981
• Report Number: 2954323-2022-03654
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71992-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 53 KG