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

Model Number 71953-01

Device Problem Data Problem (3196)

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

Event Date 11/03/2021

Event Type  Injury  

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.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.

Event Description

A customer reported that the freestyle libre 2 reader did not depict her low glucose values on the graph and she was therefore unable to determine if she was hypoglycemic.The customer experienced a loss of consciousness; however, she was able to regain consciousness on her own and self-treat with biscuits and food.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that the freestyle libre 2 reader did not depict her low glucose values on the graph and she was therefore unable to determine if she was hypoglycemic.The customer experienced a loss of consciousness; however, she was able to regain consciousness on her own and self-treat with biscuits and food.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported reader mbma332-j0971 has been returned and investigated.Visual inspection was performed and no issues were observed.The data time period was was analyzed and it was determined during this time period that the customer changed the time/date.This causes a gap from the point at which the date was changed, to the date it was changed to.Therefore, this complaint is not confirmed.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.

• 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: 12814309
• MDR Text Key: 280772919
• Report Number: 2954323-2021-92530
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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 Returned to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: 11/04/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 57 KG