Medtronic MiniMed

Model: Models: MMT-511, MMT512, MMT-515, MMT-522, MMT-554, MMT-712, MMT-715, MMT-722, MMT-754, Affected: All serial numbers

Model: Models: MMT326A & MMT-332A, Affected: Lots: H8442973, H8469703, H8496561, H8517079, H8463297, H8492449, H8510440, H8539013, H8467888, H8494645, H8512826

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Medtronic MiniMed CareLink Pro 4.0 model MMT-7335WWP and Clinical model MMT-7334

General Hospital and Personal Use Devices

2

No

Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)

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.

General Hospital and Personal Use Devices

2

No

Australia, Czech Republic, Denmark, Finland, France, Ireland, Netherlands, Norway, Sweden, United Kingdom.

MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712.