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

Model Number 71953-01

Device Problem Failure to Power Up (1476)

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

Event Date 12/25/2021

Event Type  Injury  

Event Description

A customer reported that after dropping the freestyle libre 2 reader, it would not power on with either button press or test strip insertion.The customer was therefore unable to obtain glucose results and became hypoglycemic, subsequently losing consciousness.The customer was treated with glucose via iv by ambulance service for hypoglycemia.There was no report of death or permanent injury associated with this event.

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 record) for the libre reader were reviewed, and the dhrs showed the libre reader 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.

Manufacturer Narrative

The returned meter was investigated.Visual inspection was performed and no issues were observed.Reader did not power on with button depression, test strip insertion or usb cable insertion.The meter was de-cased and visual inspection was performed and liquid contamination was observed.Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported that after dropping the freestyle libre 2 reader, it would not power on with either button press or test strip insertion.The customer was therefore unable to obtain glucose results and became hypoglycemic, subsequently losing consciousness.The customer was treated with glucose via iv by ambulance service for hypoglycemia.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: 13120803
• MDR Text Key: 283081727
• Report Number: 2954323-2021-97422
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 72 KG