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

Model Number 71953-01

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

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

Event Date 10/31/2023

Event Type  Injury  

Manufacturer Narrative

Reader (b)(6) was returned and investigated with retained strips.Visual inspection has been performed on reader and no issues were observed.A control solution test was performed, and all results were satisfactory.The complaint is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre reader was reviewed and the dhrs showed the freestyle libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A testing issue was reported with the adc device.The customer reported the test did not start after the blood sample was applied and he was unable to obtain readings.Customer experienced a loss of consciousness and was able to self-treat by eating something.Customer had contact with a non-healthcare professional (non-hcp) third-party who provided nutritional advice and glucose as treatment.In addition, customer made an appointment with an hcp who checked the customer's glucose levels.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: 18264628
• MDR Text Key: 329664113
• Report Number: 2954323-2023-52598
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00357599803001
• UDI-Public: 00357599803001
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 11/21/2023
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• 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