CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Class I - DangerousWhat Should You Do?
- Check if you have this product: n/a
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic MiniMed Inc.
- Reason for Recall:
- Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error that resulted in an inaccurate time zone being applied to 19 CareLink iPro reports.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information
Product Codes/Lot Numbers:
n/a
Distribution:
Distributed in: US, MN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1501-2016
Related Recalls
CareLink Clinic, REF: MMT-7350
Medtronic MiniMed
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Medtronic MiniMed
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medtronic MiniMed
Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.