A 29-year-old Chilean man is seeking 101.5m pesos after alleging that a faulty NovoRapid FlexPen failed to deliver his insulin and triggered a severe hyperglycaemic episode.
A Chilean patient has filed a lawsuit against Novo Nordisk, accusing the company of a defect in a NovoRapid FlexPen insulin device that he says left him dangerously close to diabetic coma, according to The Clinic. The suit seeks 101.5 million pesos, plus interest, inflation adjustments and costs, over what it describes as a factory fault in a pen supplied through Chile’s GES public health system.
The claimant, identified as Sebastián Irarrázaval, is a 29-year-old man diagnosed with type 1 diabetes in childhood. Court filings quoted by The Clinic say he followed the manufacturer’s instructions on 28 August 2024 before injecting his daily dose, but the device allegedly malfunctioned when a rubber plunger component failed to push the insulin through properly after a plastic part detached from its shaft. As a result, he says, he did not receive the insulin he believed he had administered and soon developed a severe hyperglycaemic episode.
According to the filing, Irarrázaval began to suffer tingling, discomfort, dizziness and palpitations before his home glucose monitor showed a “high” reading. He later went to the emergency department at Clínica Alemana in Santiago that evening and was discharged hours later with instructions to see his diabetes specialist as soon as possible. The Clinic reported that the hospital sought distributor details so that any wider device problem could be checked, given the potential risk to insulin-dependent patients.
The dispute also centres on what happened after the episode. The Clinic said the patient contacted his treating diabetologist the next day and was asked to hand over the pen so the company could examine it, but the claim says he resisted doing so unless the device would be returned. Novo Nordisk later ended discussions, according to a letter cited by the publication, saying it could not accept the complaint without access to the device and noting that it had found no problem in other medicines from the same batch. In support of its case, the claimant argues that the pen was covered by GES and that any manufacturing flaw could affect a wider group of patients who rely on the same treatment.
The wider context is mixed. NovoRapid FlexPen, which contains insulin aspart, is intended to lower blood glucose and requires careful dosing, monitoring and correct injection technique, as set out in product information from Chilean pharmacy databases. At the same time, safety and regulatory records show that complaints about insulin delivery devices are not always linked to manufacturing defects: the US Food and Drug Administration’s MAUDE database includes a serious injury report involving a Novo Nordisk insulin pen in which technique and device use were also in question, while Medsafe in New Zealand reviewed reports of reduced efficacy with NovoRapid Penfill and found no quality issue after testing. In Brazil, a court case involving a similar device also concluded that the problem arose from incorrect handling rather than a factory fault.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
