Medtronic is recalling some models of insulin pumps in a rare example of a medical device recall over a cybersecurity issue.
The insulin pumps subject to the recall connect wirelessly to other insulin equipment, including glucose meters, a monitoring system and controls that pump insulin.
"The FDA is concerned that, due to cybersecurity vulnerabilities identified in the device, someone other than a patient, caregiver or health care provider could potentially connect wirelessly to a nearby MiniMed insulin pump and change the pump's settings. This could allow a person to over deliver insulin to a patient, leading to low blood sugar ... or to stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis," the FDA notice says.
The MiniMed 508 pumps can't be updated to address security flaws in the device's firmware, according to the notice. The company is offering alternatives with "enhanced built-in security capabilities.", Medtronic urged customers to speak with their healthcare providers about whether to change the pump.
Medtronic has identified around 4,000 patients using the insulin pumps today, and is "working with distributor partners to identify additional patients potentially using the pumps."
México Últimas Noticias, México Titulares
Similar News:También puedes leer noticias similares a ésta que hemos recopilado de otras fuentes de noticias.
Judge throws the book at a clinic offering unproven stem cell ‘treatments’In what may be the harshest enforcement order yet against a clinic pitching unproven and potentially harmful stem cell “treatments,” a federal judge has ordered a stem cell firm to cease offering the treatments. Columnist hiltzikm explains:
Leer más »
FDA issues warnings to companies selling kratom products for opioid addictionThe federal agency says the companies are using websites and social media to illegally market the popular herbal supplement by making unproven claims.
Leer más »
Opinion | The FDA’s Challenge on E-CigsOpinion: The dramatic rise of e-cig use by young people demands FDA action, writes former FDA commissioner ScottGottliebMD
Leer más »
FDA approves expanded label for Regeneron/Sanofi's DupixentThe U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceut...
Leer más »
The FDA Wouldn't Let This 24-Year-Old Give Blood — So He Donated A Kidney Instead'It's something that really didn’t impact me much, but it can really make a difference for somebody else,' Barton Lynch says
Leer más »
FDA Tests Find Toxic Chemicals in FoodThe FDA -- for the first time -- has tested food on grocery store shelves for toxic grease and stain-repelling chemicals called PFASs that are known to stick around in the body and the environment for long periods of time.
Leer más »