Summary Safety Review - Paradigm insulin infusion pump - Assessing the potential risk of malfunctions with the device

October 23, 2017

Product

Paradigm insulin infusion pump manufactured by Medtronic MiniMed

Potential Safety Issue

Risk of device malfunctions: loose drive support cap, keypad issues and blank screens

Key Messages

  • The Paradigm insulin infusion pump is a medical device licensed for sale in Canada to give insulin and help diabetic patients manage their blood sugar levels.
  • Health Canada performed a review to assess the effectiveness of changes to the pump following recommendations from a previous review in 2015.
  • The current review identified additional issues relating to loose drive support caps, keypad problems and blank screens. These malfunctions may lead to the patient’s blood sugar becoming too high or too low.
  • Health Canada will monitor and reassess these issues in 2 years as the manufacturer is making additional changes to the pump to address current issues.

Overview

In 2015, Health Canada reviewed the risk of problems  with the Paradigm insulin infusion pump following reports involving the drive support cap as well as the keypad. In 2017, Health Canada wrote another review to assess the effectiveness of changes to the pump and identified additional issues to monitor. The 2017 review assessed complaints reported between 2015 and 2016.

Use in Canada

  • The Paradigm insulin infusion pump is a medical device licensed for sale in Canada to give insulin and help diabetic patients manage their blood sugar levels.
  • Some of the issues are due to user errors. Patientsare reminded to carefully read the pump’s instructions to ensure that they are using the device correctly and not to expose the pump to water during activities like swimming, showering or bathing, as the pump is not waterproof.
  • The pump has been licensed in Canada since May 2002. Between 2011 and 2016, approximately 38,300 pumps were distributed in Canada. The life-span of the pump is 4 years.

Safety Review Findings

Loose drive support cap

  • The drive support cap holds the pump motor in place so that the pump can give insulin to the patient. If the pump is dropped or bumped, the cap can become loose and the pump may stop working. If the patient pushes the cap back into position, it can give an extra dose. In March 2013, the manufacturer made a design change to the pumps to better hold the cap in place.
  • There have been 106 complaints between 2015 and 2016. Of these complaints 3 reported severely high blood sugar requiring hospitalization, but only 2 cases were confirmed to be due to loose drive support caps. Another 7 reported moderately high blood sugar which the patient treated themselves.
  • A total of 76 pumps were returned and examined, 54 of which were not working properly and 22 had no malfunctions identified. Among the 54 that were not working properly, 47 had the old support cap design.
  • The manufacturer is making an additional design change to better prevent the cap from loosening. By the end of November 2017, all new pumps should have this new design change.

Keypad issues

  • Keypad malfunctions are reported as either complaints of a button error alarm or the keypad not working due to moisture getting inside and leading to damage (corrosion) of the electronic surfaces. In August 2014, new keypads were introduced to address the moisture issue, which greatly reduced the number of complaints. However, some reports continued to be received when the pumps were exposed to water during swimming and showering as the pumps are not waterproof. Moreover, two new issues with the keypad (i.e., flattened dome switch and unlocked J2/LCD keypad connector) were noted in the investigation of the keypad complaints.
  • There were a total of 3,139 keypad complaints between 2015 and 2016. Of these complaints, 8 patients reported severely high blood sugar and 4 reported severely low blood sugar requiring hospitalization or emergency medical services. Another 61 patients reported moderately high blood sugar and 18 reported moderately low blood sugar, but they were able to safely treat themselves.
  • Of the 2,312 pumps that were returned and examined, 953 were found to work properly, 1,046 presented moisture damage, 182 had flattened dome switches, 115 had a J2/LCD keypad connector issue and 17 had other problems. Out of the 1,046 returned pumps with moisture damage, 1,019 pumps had the old keypad design.
  • The manufacturer is working on design changes to further prevent these issues (i.e., flattened dome switch and unlocked J2/LCD keypad connector) and in 2 years Health Canada will conduct a follow-up review.

Blank screen

  • A total of 362 complaints were received between 2015 and 2016. Of these complaints, 14 of the patients experienced moderately high blood sugar and treated themselves. One patient was hospitalized twice for severely high blood sugar, but the returned pump was working properly when examined.
  • A total of 197 pumps were returned to be examined. For 47 of the returned pumps, the cause was determined to be moisture damage (i.e., corrosion) to either the electronic assembly/LCD board (28) or battery tube/battery cap (19). Of these 47 pumps, 12 were newly redesigned models that showed signs of physical damage, possibly related to being dropped during use. Another 21 had electronic defects and 3 had physical damage to the display or battery tube spring. The remaining 126 returned pumps were found to be working properly.
  • User errors were the main cause of blank screens. Users are reminded to carefully read the pump’s instructions to ensure that they are using the device correctly, and not to expose the pump to water during activities like swimming, showering or bathing since the pump is not waterproof.

Conclusions and Actions

  • The design changes made by the manufacturer have greatly reduced the number of new complaints and the majority of the issues reported have been with older pump models, which are nearing the end of their expected use.
  • Users are reminded to carefully read the pump’s instructions to ensure that they are using the device correctly and not to expose the pump to water during activities like swimming, showering or bathing, as the pump is not waterproof.
  • Health Canada will monitor and reassess these issues in 2 years, including the actions taken by the manufacturer to address current issues.
  • Health Canada will continue to monitor safety information involving the Paradigm insulin infusion pump, as is the case for all medical devices on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely actions if and when any new health risks are identified.

Additional Information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international safety information, and what is known about the use of this device both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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