Paradigm 1.5ML Reservoir, Model 326

• • Terminated Z-1986-2013 FDA Class II ·initiated 3 Jul 2013

  Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not

510(k) Number

K001828 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K031390 Active Cleared 23 Jul 2003

• Mimimed Sil-Serter Infusion Set Insertion System, Model 385

  Class II

  FDA 510(k) K010377 Active Cleared 5 Apr 2001

• Medtronic Minimed Paradigm Model 512 Insulin Pump and the Bd Paradigm Link Glucose Meter

  Class II

  FDA 510(k) K030531 Active Cleared 17 Jun 2003

• Minimed Paradigm Insulin Pump, Model 511

  Class II

  FDA 510(k) K001829 Active Cleared 18 Aug 2000

• Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311

  Class II

  FDA 510(k) K021974 Active Cleared 6 Aug 2002

• Paradigmpal, Model Mmt-7330

  Class II

  FDA 510(k) K031541 Active Cleared 18 Nov 2003

See all devices from Minimed, Inc. →

• What is the Paradigm 1.5ml Reservoir, Model 326 used for?

  The Paradigm 1.5ml Reservoir, Model 326, is a reservoir component specifically designed for insulin infusion pumps. It holds 1.5ml of insulin and delivers it through a connected infusion set, ensuring precise insulin administration for diabetes management in both home and clinical settings. The reservoir interfaces with traditional Luer Lock systems, making it compatible with the Medtronic MiniMed 5 Series Insulin Pumps.

• How is the Paradigm 1.5ml Reservoir, Model 326 supplied and what are its sterility and reuse details?

  The Paradigm 1.5ml Reservoir, Model 326, is supplied as a single-use component and is non-sterile. It is intended for one-time use only, which helps maintain patient safety and system integrity. Reuse is not recommended or supported by the manufacturer, as it could compromise the device’s functionality and the accuracy of insulin delivery.

• Is this reservoir compatible with other insulin pump models?

  The Paradigm 1.5ml Reservoir, Model 326, is specifically designed for compatibility with the Medtronic MiniMed 5 Series Insulin Pumps. While it features a Luer Lock system for general compatibility, it is not intended for use with other pump models unless explicitly stated by the manufacturer. Always verify compatibility with your specific insulin pump system before use.

• How should the Paradigm 1.5ml Reservoir, Model 326 be stored?

  The Paradigm 1.5ml Reservoir, Model 326 should be stored according to the manufacturer’s guidelines to ensure proper functionality and patient safety. Since it is non-sterile and single-use, it should be kept in a clean, dry place, protected from direct sunlight and extreme temperatures. Avoid storing it in environments where it could be exposed to moisture or contaminants, as this could compromise its integrity before use.

• Is the Paradigm 1.5ml Reservoir, Model 326 MRI-safe?

  No, the Paradigm 1.5ml Reservoir, Model 326 is not MRI-safe. It should not be used or stored in proximity to MRI machines, as exposure to magnetic fields could potentially damage the device or pose safety risks. Always follow manufacturer instructions regarding safe handling and usage environments.