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

Model Number 71953-01

Device Problem No Display/Image (1183)

Patient Problems Hypoglycemia (1912); Muscle Weakness (1967); Confusion/ Disorientation (2553)

Event Date 07/14/2022

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 fs 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 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 touch screen issue was reported with the adc device.A customer reported encountering an issue for the past 3 weeks where they ¿could not press on the screen for readings¿.The customer became hyperglycemic with symptoms of confusion, light-headedness, and weakness, and was unable to self-treat.The customer was treated with juice and biscuits by a third party and no further information was provided.There was no report of death or permanent injury associated with this event.

Event Description

A touch screen issue was reported with the adc device.A customer reported encountering an issue for the past 3 weeks where they ¿could not press on the screen for readings¿.The customer became hyperglycemic with symptoms of confusion, light-headedness, and weakness, and was unable to self-treat.The customer was treated with juice and biscuits by a third party and no further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Section d-4 (serial number) and h-4 device mfg date) have been updated based on the returned product.Reader (b)(6) was returned and investigated.Performed visual inspection on returned reader an no issues were observed.A touchscreen test was performed and observed the touchscreen responded properly.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A touch screen issue was reported with the adc device.A customer reported encountering an issue for the past 3 weeks where they ¿could not press on the screen for readings¿.The customer became hyperglycemic with symptoms of confusion, light-headedness, and weakness, and was unable to self-treat.The customer was treated with juice and biscuits by a third party and no further information was provided.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Section d-4 (serial number) and h-4 device mfg date) have been updated based on the returned product.Reader (b)(6) was returned and investigated.Performed visual inspection on returned reader an no issues were observed.A touchscreen test was performed and observed the touchscreen responded properly.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.An extended investigation has aslo been performed for the reported complaint.There was no indication that the product did not meet specification.Dhrs for the fs libre reader were reviewed and the dhrs showed the fs libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Section h-6 (adverse event problem) and h-10 (addtl mfg narrative) were incorrectly documented in the previous follow up #1 report.H-6 and h-10 have been updated to include the extended investigation results.

• 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: 15189174
• MDR Text Key: 297491672
• Report Number: 2954323-2022-27927
• 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,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• 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: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2020
• 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