When consumers hear of dosage errors, people typically think about a pharmacist filling the wrong dose or someone overdosing themselves. However, many people do not consider that dose errors can also occur due to malfunctioning pumps and equipment that people use to administer their medication. Recently, the U.S. Food and Drug Administration (FDA) announced a safety alert regarding Medtronic’s insulin pump and the potential for insulin dose errors.
Patients with diabetes who use the MiniMed Paradigm insulin pump from Medtronic should know that they are at risk for a potential dosing error. The error can occur when insulin from the pump moves through the disposable tubing and enters the body through a soft cannula. If insulin or other liquid then contacts the inside of a tubing connector, it is possible that the insulin can clog the vents in the tubing connector. When this happens, too much or too little insulin can be delivered, resulting in a dosing error and leading to either hyperglycemia or hypoglycemia, that may cause unconsciousness or death.
Apparently, Medtronic notified patients about the potential safety concern and explained that a new reservoir and infusion set would be needed if the insulin reservoir becomes wet. Although the alert is considered a Class I recall, the company’s spokesperson Amanda Sheldon told Medscape Medical News that, “customers do not need to return the MiniMed Paradigm infusion sets because they will work as intended if the pump instructions are followed.”
If you have been harmed by this Medtronic insulin pump and have suffered the results of an insulin dose error, you may have rights to seek damages. To find out about your legal rights surrounding your prescription dosing error, contact an experienced medication error attorney at Kennedy Hodges at 888-526-7616 for a free initial consultation.