CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designe...
FDA Device Recall #Z-1228-2015 — Class III — November 10, 2014
Recall Summary
| Recall Number | Z-1228-2015 |
| Classification | Class III — Low risk |
| Date Initiated | November 10, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic MiniMed Inc. |
| Location | Northridge, CA |
| Product Type | Devices |
| Quantity | 5 CareLink Pro 4.0 CD ROMs |
Product Description
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: - read and store history and settings data supported insulin pump models and supported blood glucose meters - read and report user-programmable settings on supported pump models - read device data from the CareLink Online system - write new device data to the CareLink system - generate reports from the patient records for use in managing the patient's therapy. CareLink Clinical Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. Both products are CD ROMs.
Reason for Recall
The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.
Distribution Pattern
Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)
Lot / Code Information
Medtronic MiniMed CareLink Pro 4.0 model MMT-7335WWP and Clinical model MMT-7334
Other Recalls from Medtronic MiniMed Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1501-2016 | Class II | CareLink iPro2 Reports, Model No. MMT-7340 is ... | Feb 19, 2016 |
| Z-0438-2016 | Class II | MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model ... | Sep 25, 2015 |
| Z-0437-2016 | Class II | MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 ... | Sep 25, 2015 |
| Z-2442-2015 | Class II | Guardian Real-Time Monitor, Model No. CSS7100. ... | Jul 22, 2015 |
| Z-2260-2015 | Class II | MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-... | Jun 19, 2015 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.