U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Pump, infusion - Product Code FRN
원인
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.
조치
An Urgent Medical Device Recall notice was sent to customers on July 3, 2013, who purchased the Medtronic Paradigm Reservoirs MMT-326A and MMT-332A. The recall letter informed the customers of the problems and the actions to be taken. Medtronic instructed customers that they will replace all reservoirs from the affected lots at no cost. Customers are instructed to refer to www.medtronicdiabetes.com/support/product-updates for a list of frequently asked questions. Customers are instructed to report adverse reactions or quality problems experienced with the use of Medtronic Diabetes insulin pumps, infusion sets or reservoirs to FDA's MedWatch Adverse Event Reporting Program. Customers are instructed to call for replacements at (866) 222-2584 Monday through Friday (8am-6pm) central time. Customers with an urgent issue may use the 24 hour helpline.
Worldwide Distribution - USA (nationwide) and the countries of Australia, Bermuda, Brazil, Canada, Chile, Columbia, Ecuador, El Salvador, Germany, Japan, Mexico, Netherland, Paraguay, Puerto Rico, Singapore, Uruguay and Venezuela.
제품 설명
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) || The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. || Product Quantity Distributed (Int) 669,672 units