Are Medtronic Quick-Set Infusion Sets Safe?
Medtronic Quick-Set Infusion Sets are supposed to deliver insulin to the body without the user needing to actively do anything. They are supposed to make managing insulin levels easier and more convenient.
It was, for this reason, users were unaware there was a problem with their set until complications arose. Their set was over- or under-dosing them with insulin and they didn’t even realize it until their bodies began to react.
These inaccurate doses of insulin triggered hyper- and hypoglycemia in some users something that can be fatal.
MiniMed Infusion Sets Were the Subject of a Recall in 2017 Due to Problems with Insulin Delivery
According to the manufacturer of MiniMed Infusion Sets, the vent on the set could become clogged or blocked during the filling or priming of the tube with medication. These clogs caused the meter to misread a patient’s need for insulin and not deliver the appropriate dosage, but users were unaware this was happening until a health problem arose.
Most users experienced problems with the clogs shortly after changing their device.
How Do I Know My Medtronic Infusion Set Might Have Malfunctioned?
In many cases, users of the Medtronic Infusion Set had no idea there was a problem with their device until they began to experience problems related to their insulin levels.
Symptoms of hyper- or hypoglycemia include:
- Rapid heartbeat
- Trembling or shaking
- Blurred or double vision
- Moodiness, primarily anger or anxiety
- Fatigue or inability to stay sleep
- Pale or tingling skin
An inspection of the Medtronic device could also reveal a problem. Users should look for anything unusual or strange, and visit the emergency room or consult their doctor immediately if they notice a problem.
Medtronic MiniMed Insulin Infusion Set Recall
The FDA announced Medtronic was issuing a voluntary Class 1 recall of its MiniMed Insulin Infusion Sets, warning users the device could over-deliver insulin shortly after the set is changed.
The recall pertains to sets distributed prior to April 2017. The company encouraged users to only use infusion sets made with the updated and corrected membranes.
Users who experience problems with their devices are encouraged to seek immediate medical attention because over- or under-dosing of insulin can cause fatal complications.
Medtronic Also Recalls Heart Defibrillators
The MiniMed Insulin Infusion Sets is not the only problem Medtronic has had with its medical devices.
In February 2018, the company had to recall 48 of its implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators because the devices failed to deliver the appropriate shock to pace a patient’s heart. These devices also failed to deliver the needed shock when patients went into cardiac arrest.
Medtronic’s defibrillators are similar to pacemakers and assist the heart in keeping a natural rhythm. They are intended to prevent death from cardiac arrest, but if there is a delay or malfunction in the device’s ability to shock the patient’s heart it can result in serious injury or be fatal.
According to the FDA, the Class I recall of the affected devices was issued because there is a defect that causes “an out of specification gas mixture inside the device” that can prevent it from delivering the shock needed.
Affected devices were manufactured between July 13, 2013, and August 8, 2017.
Medtronic is asking doctors to replace the defibrillators and has agreed to offer a supplemental device warranty for those affected. The FDA has asked doctors and defibrillator users to report any adverse events to the agency’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.