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

Model Number 71953-01

Device Problem No Device Output (1435)

Patient Problems Hyperglycemia (1905); Malaise (2359)

Event Date 06/30/2022

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 determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader was 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 complaint was received reporting that the adc device did not start test after the sample was applied to the test strip.The customer experienced feeling unwell while at school and was provided 2iu subcutaneous insulin by a non-healthcare professional, as instructed by a healthcare professional, for treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection was performed on the returned reader; no issues were observed.Control solution testing was attempted to perform.Test did not fire.The reader was de-cased and visual inspection was performed.Debris were observed inside strip port.Therefore, issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A complaint was received reporting that the adc device did not start test after the sample was applied to the test strip.The customer experienced feeling unwell while at school and was provided 2iu subcutaneous insulin by a non-healthcare professional, as instructed by a healthcare professional, for treatment.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: 14950974
• MDR Text Key: 295473408
• Report Number: 2954323-2022-22807
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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