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

Model Number 71953-01

Device Problem Power Problem (3010)

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

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

Reader (b)(4) has been returned and investigated with returned data cable.Visual inspection has been performed on the meter reader and data cable.Damage was observed on the usb port.The damage to the usb port prevented the reader from charging.The data cable was also inspected and no issues observed.The reader was placed into a test fixture to download log.Therefore, issue is not confirmed to use.The dhrs (device history record) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer was unable to test using the adc device as the meter only turns on with data cable.Customer experienced "felt low," a loss of consciousness and was unable to self-treat.Customer had contact with a healthcare professional who provided orange juice as treatment.No further information was provided.There was no report of death or permanent impairment 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: 15414713
• MDR Text Key: 299831084
• Report Number: 2954323-2022-33453
• 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: 09/13/2022

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
• Device Catalogue Number: 71953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2021
• 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
• Patient Sex: Male