NATIONAL NEWS

Death Linked To Insulin Pump Leads To Recall Of More Than 300,000 Devices

Feb 13, 2020, 8:46 AM | Updated: 8:47 am

(CNN) –– Medtronic has recalled some of its insulin pumps after injuries and one death were reported due to the device malfunctioning, according to a US Food and Drug Administration announcement on Wednesday.

The FDA identified it as a Class I recall, the most serious type of recall.

Insulin pumps are small devices that can deliver insulin and help diabetes patients reach desired blood glucose levels as part of their management of the disease.

Medtronic has recalled certain MiniMed 600 Series insulin pumps for delivering incorrect insulin dosing due to a missing or broken retainer ring, which helps lock the insulin cartridge in place in the pump’s reservoir compartment, the FDA announcement said. The recall includes about 322,000 devices.

“There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. The retainer ring can be broken, for example, as a result of dropping or bumping your pump on a hard surface,” said a safety notification letter that Medtronic sent to patients in November.

“At Medtronic, patient safety is our top priority, and we are committed to delivering safe and effective therapies of the highest quality and reliability possible. We appreciate your time and attention in reading this important notification,” the letter said.

The FDA announcement said that there have been 26,421 complaints regarding device malfunction, 2,175 injuries and one death.

In these devices, when the insulin cartridge is not properly locked in place that can interrupt how much insulin is delivered, which could lead to hypoglycemia, known as having low blood sugar, or hyperglycemia, known was having high blood sugar. Signs of hypoglycemia include dizziness, confusion and feelings of weakness. Severe cases of hyperglycemia can lead to loss of consciousness, seizure or death.

As listed on the FDA’s website, Medtronic has recalled the following pump models:

  • Model 630G distributed in September 2016 to October 2019
  • Model 670G distributed in June 2017 to August 2019

The FDA announcement noted that Model 630G may be used by people 16 and older, and Model 670G may be used by people 14 and older. Any users of these devices are encouraged to talk to their doctors.

The letter that Medtronic sent to patients using these pumps encourages them to examine the trainer ring used in their pumps. If the reservoir does not lock into the pump properly or the ring is loose, damaged or missing, the letter says to stop using the insulin pump and instead use manual insulin injections per your doctor’s recommendations.

If your reservoir properly locks in place by the retainer ring, the company said you may continue using your pump, but remember to always follow the device instructions and routinely examine your pump retainer ring, according to the letter. If you happen to drop the pump, check to make sure there is no damage to the device and its retainer ring.

The FDA announcement noted that affected patients can contact Medtronic for a replacement pump if the reservoir does not lock into place properly or if the retainer ring is loose, damaged or missing.

Patients with questions about the recall are encouraged to call the 24-hour Medtronic Technical Support line at 877-585-0166.

This isn’t the first time that there has been a recall of certain MiniMed insulin pumps.

In June, the FDA issued a warning about possible risk of hacking for some of the MiniMed Paradigm models. In its warning at the time, the FDA noted that these devices pose the risk of someone nearby connecting wirelessly and then potentially hacking into the devices.

KSL 5 TV Live

Top Stories

National News

Post-tropical storm Fiona in Irish Cova, Nova Scotia on Cape Breton Island in Canada Sept. 24, 2022...
ROB GILLIES Associated Press

Fiona washes houses away, knocks out power in Canada

Strong rain and winds are lashing the Atlantic Canada region as Fiona hits as a powerful post-tropical cyclone. Canadian forecasters are warning it could be one of the most severe storms in the country's history. Fiona made landfall in Nova Scotia before dawn Saturday after transforming from a hurricane into a post-tropical cyclone. Forecasters caution that despite the change, Fiona still has hurricane-strength winds and will bring drenching rains and huge waves. More than 500,000 customers in Atlantic Canada are affected by outages. Ocean waves pounded the town of Channel-Port Aux Basques on the southern coast of Newfoundland, where entire structures were washed into the sea.
14 hours ago
An illustration shows NASA's DART spacecraft and the Italian Space Agency's LICIACube prior to impa...
Ashley Strickland, CNN

What will be visible when DART spacecraft crashes into tiny asteroid

The NASA Double Asteroid Redirection Test aims to make history on Monday at 7:14 p.m. ET when it slams into Dimorphos, a tiny asteroid moon orbiting the larger asteroid Didymos.
2 days ago
NASA’s Artemis I rocket sits on launch pad 39-B at Kennedy Space Center as it is prepared for an ...
MARCIA DUNN, AP Aerospace Writer

Approaching storm may delay launch try for NASA moon rocket

NASA's new moon rocket could face more launch delays, this time by tropical weather.
2 days ago
Arizona Governor Doug Ducey speaks at a Make America Great Again campaign rally on October 19, 2020...
BOB CHRISTIE, AP

Arizona judge: State can enforce near-total abortion ban

Arizona can enforce a near-total ban on abortions that has been blocked for nearly 50 years, a judge ruled Friday, meaning clinics across the state will have to stop providing the procedures to avoid the filing of criminal charges against doctors and other medical workers.
2 days ago
Courtesy 20th Century Studios
23 Sep 22...
Jason Carroll and Lisa Respers France, CNN

James Cameron says ‘Avatar 2’ is ‘more emotional’ than the original

James Cameron spoke to the differences of the new film.
2 days ago
WASHINGTON, DC - File photo: House Minority Leader Kevin McCarthy (R-CA).(Photo by Liz Lynch/Getty ...
LISA MASCARO AP Congressional Correspondent

McCarthy unveils House GOP’s midterm agenda in Pennsylvania

House Republican leader Kevin McCarthy on Friday confronted President Joe Biden and the Democratic majority in Congress with a conservative midterm election agenda filled with Trump-like promises, working not only to win over voters but to hold together the uneasy coalition of his own party that has struggled to govern.
2 days ago

Sponsored Articles

young woman with stickers on laptop computer...
Les Olson

7 ways print marketing materials can boost your business

Custom print marketing materials are a great way to leave an impression on clients or customers. Read for a few ideas to spread the word about your product or company.
young woman throwing clothes to organize a walk in closet...
Lighting Design

How to organize your walk-in closet | 7 easy tips to streamline your storage today

Read our tips to learn how to organize your walk-in closet for more storage space. These seven easy tips can help you get the most out of your space.
Types of Computer Malware and Examples...
PC Laptops

5 Nasty Types of Computer Malware and Examples | Everything You Need to Know to Keep Your Computer and Family Safe

Here are the different types of computer malware and examples that could potentially infect your computer.
tips how to quit smoking...

7 Tips How to Quit Smoking | Quitting Smoking Might be One of the Hardest Things You Ever Do but Here’s Where You Can Start

Quitting smoking cigarettes can be incredibly difficult. Here are 7 tips how to quit smoking to help you on your quitting journey.
Photo: Storyblocks...
Blue Stakes of Utah 811

Blue Stakes of Utah 811: 5 Reasons To Call 811 Before You Dig When Working in Your Yard

Call before you dig. Even at home, you could end up with serious injuries or broken utilities just because you didn't call Blue Stakes of Utah 811.
Days of...
Days of '47 Rodeo

TRIVIA: How well do you know your rodeo? Take this quiz before you go to the Days of ’47!

The Utah Days of ’47 Rodeo presented by Zions Bank is a one-of-a-kind Gold Medal Rodeo being held July 20-23, 25 at 7:30 PM. The Days of ’47 Rodeo How well do you know your rodeo trivia? Take the quiz to test your know-all before heading out to the Days of ’47 Rodeo at the […]
Death Linked To Insulin Pump Leads To Recall Of More Than 300,000 Devices