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

• • Terminated Z-1007-2007 FDA Unclassified (pre-2012) ·initiated 27 Apr 2007

  Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi

• • Terminated Z-0010-05 FDA Unclassified (pre-2012) ·initiated 14 Sep 2004

  Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.

• • Terminated Z-0763-04 FDA Unclassified (pre-2012) ·initiated 29 Jan 2004 ·on shared 510(k) K030531

  39 lots of BD Test strip may produce an increased frequency of E-3 messages when used during blood glucose testing.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K030531 ↗

FDA Product Code

LZG

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Medtronic Minimed Paradigm Insulin Pump, Model Mmt-712 Open recall

  Class II

  FDA 510(k) K031390 Active Cleared 23 Jul 2003

• Paradigm 1.5ML Reservoir, Model 326

  Class II

  FDA 510(k) K001828 Active Cleared 18 Aug 2000

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

  Class II

  FDA 510(k) K010377 Active Cleared 5 Apr 2001

• 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. →