Medical device manufacturer, Medtronic Inc., has issued a medical device safety alert concerning the model MMT-326A and MMT-332A insulin reservoirs used with Paradigm insulin pump. The affected lot numbers in Hong Kong are H8473271, H8492449 and H8627745.
The manufacturer recalls these reservoirs due to the potential that reservoirs from these lots are at increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended and, if there is an occlusion in the infusion set, the pump may not alarm. Under-delivery of insulin can cause high blood sugar, which if untreated can lead to diabetic ketoacidosis. In most cases, the impact of a leaking reservoir is limited to a temporary increase in glucose levels. The manufacturer received a small number of reports of patients being hospitalized for diabetic ketoacidosis as a result of insulin under-delivery due to the reservoir leaking. The manufacturer has not been aware of any adverse incidents related to the above mentioned issues in Hong Kong.
Their investigation has indicated that this increased potential for reservoir leakage is related to abnormal wear of a manufacturing tool involved in the production of a component used in the affected lots of reservoirs. The manufacturer has implemented additional testing and inspection steps to ensure that currently produced reservoirs will not be subject to this problem.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 July 2013