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); Dizziness (2194)

Event Date 11/17/2022

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 there was no indication that the product did not meet specification.Dhrs for the freestyle freedom lite meter and freestyle freedom lite strips were reviewed and the dhrs showed the freestyle freedom lite meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date of event 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 customer reported that upon applying the sample to the strip, the adc device shuts off.The customer indicated due to this issue, they were unable to obtain readings when they experienced dizziness and weakness.The customer received treatment of candy and (b)(6) provided by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

Event Description

A customer reported that upon applying the sample to the strip, the adc device shuts off.The customer indicated due to this issue, they were unable to obtain readings when they experienced dizziness and weakness.The customer received treatment of candy and coca cola provided by a non-healthcare professional.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The reported meter (b)(6) was returned and visually inspected and observed damaged usb port.The damaged usb port would prevent the customer from charging the reader which would lead to the reader not turning on.The reader was de-cased and placed into the reader test fixture to download log.Therefore 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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 15974150
• MDR Text Key: 305412387
• Report Number: 2954323-2022-45678
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• 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: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2021
• 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