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

Model Number 71952-01

Device Problems No Display/Image (1183); Unable to Obtain Readings (1516)

Patient Problems Loss of consciousness (2418); Convulsion/Seizure (4406)

Event Date 04/15/2021

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.The dhrs (device history review) 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 the adc freestyle libre 2 reader turned on with a blank screen.On (b)(6) 2021, as a result, the customer stated they had a "heart attack," which is reported as part of their health history, as they were unable to monitor their blood glucose.The customer had a seizure and loss of consciences and received unspecified treatment and "ehag" by an hcp.The customer did not provide additional information.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported the adc freestyle libre 2 reader turned on with a blank screen.On (b)(6) 2021, as a result, the customer stated they had a "heart attack," which is reported as part of their health history, as they were unable to monitor their blood glucose.The customer had a seizure and loss of consciences and received unspecified treatment and "ehag" by an hcp.The customer did not provide additional information.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader mcga193-j2627 has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.The reader powered on with button depression, but an unexpected screen appearance was observed.Unable to perform a built-in reader test due to a display issue.An extended investigation was also performed.A visual inspection performed on the returned reader, a damaged liquid crystal display (lcd )screen was observed.De-cased the reader and did not observe any damage to the printed circuit board assembly (pcba).The damage to lcd could only be caused by an external impact to the center of the lcd resulting in the lcd cracking.This issue is not confirmed to use.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
• MDR Report Key: 11733547
• MDR Text Key: 247554295
• Report Number: 2954323-2021-67583
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599804008
• UDI-Public: 00357599804008
• 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: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71952-01
• Device Catalogue Number: 71952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR