Blog
Urgent Medical Device Correction
- By: Maureen Carland
- On: 07/31/2024 09:29:59
- In: Quality/Regulatory
Abbott has identified that some FreeStyle Libre 3 sensors may provide incorrect high glucose readings. These inaccuracies, if undetected, could pose a significant health risk for individuals living with diabetes by leading to incorrect treatment decisions, such as unnecessary insulin administration. Such errors can result in hypoglycemia, a potentially life-threatening condition characterized by low blood sugar.
The affected sensors are from the following lot numbers:
T60001948
T60001966
T60001969
This does not apply to all FreeStyle Libre 3 sensors, to determine if a current sensor or any unused sensors are affected, got to Confirm Sensor Serial Number
What to do if your sensors are affected:
1. Discontinue Use- Users with affected sensors should immediately stop using them and dispose of them properly.
2. Replacement- Abbott is offering free replacements for affected sensors. After confirming the status of your sensor on their website, users will be guided to provide contact information to receive replacement sensors at no cost.
3. Verification of symptoms- If there are symptoms that do not align with the sensor glucose readings, or if there is any suspicion of inaccuracy, users should conduct an alternative method to verify glucose reading, and/or seek immediate medical advice.
For further information or to report adverse reactions or quality issues, contact Abbott customer service at 1-833-815-4273, available 7 days a week from 8 a.m. to 8 p.m. Eastern Time, excluding holidays.
Additionally, reports can be submitted to the FDA's MedWatch Adverse Event Reporting program by completing Form FDA 3500 online at www.FDA.gov, or by calling 1-800-FDA-1088.
Staff contact: mcarland@mehca.org