FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Recall
- Recall Number
- Z-2692-2024
- Event Number
- 95047
- Firm
- Abbott Diabetes Care, Inc.
- FEI Number
- 3002803444
- Product Code
- QLG
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- July 24, 2024
- Posted
- August 27, 2024
- Address
- 1360 S Loop Rd, Alameda, CA, 94502-7000
Description
FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 Continuous Glucose Monitoring System
Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously high glucose results. The inaccurate higher glucose values may lead to users calculating higher insulin bolus correctional doses based on inaccurate CGM glucose data. The inaccurate higher glucose values may also contribute to missed or delayed recognition of hypoglycemia, when the sensor incorrectly reports normal or even high glucose values when the actual glucose is trending low or is low. If the hypoglycemia missed by the device occurs acutely, a user may not be able to confirm the actual glucose with a self-monitored blood glucose (BG) and/or administer prompt intervention to raise glucose levels. The over-delivery of insulin and/or the missed or delayed detection of impending or overt hypoglycemia in the worst-case scenario may lead to severe hypoglycemia/hypoglycemic crisis with significant adverse health consequences. Such consequences include central nervous system dysfunction, loss of consciousness, seizure activity and may lead to coma, permanent neurological damage, and death.
On 7/24/24, correction notices were distributed to customers, distributors, wholesalers. In addition, a news release was posted. FSL3 app users started receiving a message, with a clickable link to the notification, prior to the starting each new senor. Customers were asked to do the following: 1) To determine if your current sensor or any unused sensors you have are affected, please visit www.FreeStyleConfirm.com and select "CONFIRM SENSOR SERIAL NUMBER". 2) If you are wearing a Sensor, you can find the Serial number in the App or Reader. The Serial Number can also be found on the bottom of the Sensor Applicator label and carton. 3) If you are currently using the system and are wearing an affected sensor, please immediately discontinue use, and dispose of any affected sensors in your possession. 4) If you have symptoms that do not match the sensor glucose reading or suspect your reading may be inaccurate, check the reading by conducting a fingerstick test using any blood glucose meter. The built-in blood glucose meter in the FreeStyle Libre 3 Reader may be used to check your glucose at any time. 5) Complete and return the response form. 6) Distributors are asked to forward the communication to any customers and distribution partners they have distributed potentially impacted lots to. If you have additional questions call the firm's customer service at 1-833-815-4273, available 7 days a week from 8 a.m. to 8 p.m. Eastern Time, excluding holidays.
US distribution to states of: NJ, PA, OH, TX, VA, CA, NY, FL, WA, MS, MN, and WY
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