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

Model Number 71953-01

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 06/01/2021

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 it has been determined that there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and freestyle libre reader, and 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 manufacturing date is unknown.The date entered in 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 he accidently changed the language of his freestyle libre 2 reader to spanish, and did not know how to change it back to english.Due to this, he was unable to obtain glucose readings, and subsequently became confused, light-headed, and lost consciousness.The customer was able to self-treat with orange juice after re-gaining consciousness.The customer was assisted by customer service to change language during troubleshooting.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 12068412
• MDR Text Key: 258383478
• Report Number: 2954323-2021-73739
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• 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?: No
• Date Manufacturer Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 80