Medtronic warns patients of MiniMed insulin pump safety issue

November 22, 2019 By Nancy Crotti Leave a Comment

Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin.

In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping it on a hard surface may break that ring, the company said. If the reservoir is not properly locked into the pump, it could lead to over- or under-delivery of insulin, which could then result in hypoglycemia or hyperglycemia. The recall covers MiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780).

A company spokesperson told the StarTribune of Minneapolis that Medtronic had received one report of a patient being hospitalized due to a retainer-ring issue, and one report of a death which may have been associated with the issue.

Medtronic advised patients to stop using the device if the reservoir does not lock into the pump or if the is loose, damaged or missing. The company also said patients who drop or bump their pumps should examine the retainer ring and check that the reservoir locks properly. All patients should routinely check the retainer ring and check that your reservoir locks in place at every set change, the company added.

The company also said it had notified the FDA of the issue. Medtronic did not immediately respond to a request for comment on the recall.

Medtronic’s MiniMed 670G system is designed to automatically track and adjust a patient’s blood sugar levels by measuring blood glucose every few minutes and automating the dosing of insulin. The automated insulin delivery system first won FDA approval in September 2016. The FDA approved the MiniMed 630G in 2017.

MDT shares were up 0.53% to $111.06 in mid-morning trading.

How 3D printing is enabling ventilator splitting
Amid the shortage of ventilators due to the COVID-19 pandemic, researchers are finding success using 3D printing to enable “ventilator splitting.” The search continues to go on for more machines, but there have already been government actions taken to increase amounts, while researchers have taken it into their own hands to create homemade-style ventilators. However,… […]
How R&D departments are coping with coronavirus
Hardly anyone’s R&D workplace has been spared all the repercussions of the COVID-19 crisis. People are working remotely, staggering their hours in laboratories to avoid too many coworkers, and relying heavily on conference calls and video meetings. Our WTWH Media sister site R&D World spoke to a few industry people to see how they’re coping… […]
Europe waives tariffs, import taxes on COVID-19 medtech
The European Commission has decided to waive tariffs and value-added taxes (VAT) on certain medical devices and personal protective equipment (PPE) coming from outside the EU during the coronavirus pandemic. The measure includes testing kits, ventilators and other medical equipment and will remain in force for six months, the commission said today. “In this emergency,… […]
FDA eases mask regulations, seeks to boost decontamination of used masks
The FDA yesterday further relaxed regulations on medical and surgical masks and face shields to ease shortages during the coronavirus pandemic, and invited companies that decontaminate masks to submit proposals for emergency authorizations. In a new guidance, the agency also gave its blessing to healthcare providers to use improvised masks during the public health emergency when… […]
BARDA opens research portal to fight COVID-19
By James Keller, Emergo Group The Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response, is seeking information from stakeholders on available medical countermeasures in development. It is particularly interested in products and technologies that have progressed into… […]
Group seeks manufacturers’ input to reduce medical supply shortages
The National Center for Manufacturing Sciences (NCMS) today announced a new partnership with the U.S. Department of Defense (DOD) and the Federal Emergency Management Agency (FEMA) to reduce the critical shortage of medical equipment and supplies due to the coronavirus pandemic. The industry organization said it is seeking feedback from advanced manufacturing companies about capability,… […]
What is medical tubing used for?
Medical tubing is designed for a number of applications that allow clinicians to administer fluid and devices or allow for gas flow. Common applications of medical tubing include ventilators and IVs, but tubing also finds uses supporting access devices and as a delivery method for other devices. For example, tubing can be used to drive […]
Hack the Crisis: Clippard expects growth as it increases production for ventilator pneumatics
Mary Gannon, Fluid Power World Cincinnati-based Clippard said today it expects to hire more staff to meet the growing demand for its components and subassemblies for ventilators, diagnostic equipment and other critical care devices to help fight the coronavirus. The company manufactures valves, electronic pressure controls, custom assemblies, cylinders, air-preparation equipment and fittings for hose… […]
EPA inspector general wants more public input on ethylene oxide exposure
The U.S. Environmental Protection Agency’s inspector general this week recommended opening a channel of communication between government officials and people who live near 25 plants that use ethylene oxide (EtO), including eight used for sterilizing medical devices. But EPA administrator Andrew Wheeler objected, publicly indicating that his office was blindsided by the request. The forum… […]
Don’t curb your enthusiasm, but be realistic about MacGyver ventilators
In a coronavirus pandemic in which patients on the best commercial ventilators will die, are garage enthusiasts ready to stand behind their work? Scott Thielman, Product Creation Studio Almost a decade ago, Dr. Robert Clark, a pulmonologist then at Regional Hospital for Respiratory and Complex Care near Seattle, approached my company with a warning and an… […]
CDC weighs DIY facemasks for the general public. Here’s the science behind mask materials.
It looks as though the U.S. Centers for Disease Control and Prevention (CDC) may end up strongly suggesting that Americans cover their faces in public until the coronavirus pandemic plays out. The Washington Post reports the recommendations now being floated would call for the use of cloth coverings instead of hard-to-find surgical and N95 masks. This great… […]