Health product recall

Minimed

Last updated

Summary

Product
Minimed
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected products

Lot or Serial Number

Model or catalog number

Minimed 630g

More than 10 numbers, contact manufacturer.

MMT-1714K, MMT-1714KRP, MMT-1714

Minimed 670g

More than 10 numbers, contact manufacturer.

MMT-1782K, MMT-1782, MMT-1782KRP, MMT-1782CRP

Minimed 770g

More than 10 numbers, contact manufacturer.

MMT-1881, MMT-1891CN

Issue

In April 2021, while finalizing the review of complaint case-2020-00909902 related to a Minimed 630g insulin pump user who was hospitalized with hyperglycemia and DKA (diabetic ketoacidosis) on 07-dec-2020, Medtronic medical safety personnel noticed that the basal rates on the pump were still set to 0.0 units (factory default), while all other programmed settings were as expected. CAPA PR531329 was initiated to understand the cause of the issue. According to the investigation performed in CAPA PR531329, the team identified the following three (3) reasons why basal insulin may not be programmed on the pump when it is recommended by users' hcp or intended/desired:
Primary root cause (or probable cause)
1. General unawareness that user settings must be manually entered prior to use of the pump. 
Contributing causes / contributing factors
1. 24hr technical support was unaware that the one (1) user failed to press "save" after reviewing the new basal profile.
2. The design of the user interface (UI) of the NGP pump was not intuitive to users that receive the pumps. The CAPA investigation identified that the majority of users with no basal setting (when intended) are the users who received a replacement pump or a pump upgrade. The observed 7-year cumulative rate of occurrence of this issue, i.e., P1, is approximately 0.02% for all pumps shipped and 0.03% for replacement/ upgrade pumps shipped.

Recall start date: Jan 27, 2022

Additional information

Details
Original published date: 2022-02-10
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

18000 Devonshire St., Northridge, California

United States, 91325

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63906