Safety Alert for Omnipod

Safety alert

2018-04-24

2018-04-24

Panama

HMP

http://www.minsa.gob.pa/informacion-salud/alertas-y-comunicados?title=&field_decree_date_value%5Bvalue%5D%5Byear%5D=2018&page=2

At the time of the 2017 review, health canada received a total of 1806 complaints associated with the pod and 28 with the pdm. the annual number of complaints by the omnipod increased in the last 3 years, from 154 reported in 2015, 550 in 2016 and 706 from january to november 2017. the following patient results were described in the incidents reported since the last review: 98 hospitalizations, 58 cases of high levels of acid (ketones) in the blood / urine with low blood ph (diabetic ketoacidosis), 824 cases of high blood sugar levels (hyperglycemia), 19 cases of low blood sugar levels (hypoglycemia), 41 cases of skin irritation and 1 death. at this time, there is not enough information to conclude that these results were related to the omnipod's malfunction. in 215 complaints, no consequences were reported for the patient. according to the manufacturer's analysis, the rates of complaints about the device malfunction (failure key modes) have increased, but are still considered low. these dysfunctions include pod error or danger alarm during operation, occlusion alarm (to warn the patient of a possible insulin administration problem), skin irritation and adhesive problems, needle mechanism failure and patients who do not they are sure if the capsule is administering insulin. as a result of the analysis of the causes of the malfunctions and the measures adopted, the manufacturer explained that pod errors and alarms are safety measures to ensure that any risk of incorrect administration of insulin is corrected quickly. this helps ensure that the user's blood sugar level is not too high or too low. the manufacturer also discussed some design changes that are underway to reduce possible malfunctions with the device. in addition, the review of the available information concluded that the increase in the number of complaints observed seemed to be related to a greater number of omnipod sales. conclusion and actions: the health canada safety review concluded that there is no new security risk for omnipod. the safety information for this medical device is appropriate in this memento. health canada will continue to monitor the safety information that involves omnipod to identify and evaluate potential damages. health canada will take appropriate and timely measures as long as new health risks are identified.