909 units Class II Mini-Med MMT-508 Insulin Pump 2

PRODUCT

Mini-Med MMT-508 Insulin Pump, indicated for the continuous
delivery of insulin at set and variable rates for the management
of diabetes mellitus in persons requiring insulin.

Recall #Z-288-0.

REASON

The pump’s software has an error in which the current basal rate
profile indicated on the pump display, was a rate programmed for
earlier in the day and different from the expected current rate
based on the pump’s present program.

CODE

Serial numbers with suffix numbers -20A2, -20A3, -20A4, -20A5.

MANUFACTURER

Mini-Med, Inc., Sylmar, California.

RECALLED BY

Manufacturer, by letter dated November 18, 1999, followed by
telephone. Firm-initiated recall ongoing.

DISTRIBUION

Nationwide.

QUANTITY

2,909 units were distributed.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.