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Ketosis increased [ketosis], hyperglycaemia [hyperglycaemia], did not deliver the complete dosage of insulin [incorrect dose administered by device], black piston rod of the pen was not in contact with the orange piston [device issue], pen did not deliver the complete dosage of insulin [device malfunction], hyperglycaemia [hyperglycaemia].Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "hyperglycaemia" beginning on (b)(6) 2018, "ketosis increased" beginning on (b)(6) 2018, "hyperglycaemia" with an unspecified onset date, "did not deliver the complete dosage of insulin" with an unspecified onset date, "black piston rod of the pen was not in contact with the orange piston" with an unspecified onset date, "pen did not deliver the complete dosage of insulin" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo (insulin delivery device) from unknown start date in (b)(6) 2018 due to "type 1 diabetes mellitus", patient's height, weight and body mass index: not reported.Medical history included type 1 diabetes (since 1988), down's syndrome, hyperthyroidism (basedow's disease), constipation.No allergies.Pre-treatment drugs include lantus, novorapid and tresiba flextouch (until (b)(6) 2018).Concomitant products included: tresiba penfill 100 u/ml (insulin degludec) solution for injection, 100 u/ml, (b)(6) 2018 to unk, movicol /01749801/(macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride), (b)(6) 2016 to ongoing, fiasp flextouch(insulin aspart) solution for injection, 100 u/ml, umuline rapide (insulin human), (b)(6) 2017 to ongoing.Treatment included: potassium chloride (potassium chloride) + "vitchy" water (non codable).Tresiba was prescribed since (b)(6) 2018 first as prefilled pen, then with cartridge since the end of (b)(6) 2018.Novopen echo was started on an unknown date in (b)(6) 2018.The glycaemia levels were fine (several hyperglycaemias were experienced by the patient on an unknown date but they were usual for this patient).From (b)(6) 2018 to (b)(6) 2018, the patient was with his parents and used a pen from his home.From (b)(6) 2018, the patient was back into the hospital and used a pen from the service with a cartridge mounted several days ago.From (b)(6) 2018 to (b)(6) 2018, the glycaemia levels were systematically high (up to 4.5 g/l).The patient also experienced high ketosis on (b)(6) 2018.The ketone level on (b)(6) 2018 was reported as 2.9mmol/l.The nurse noted that when she unscrewed the pen the black piston rod seemed to have an issue.It might not have been in contact with the orange piston.The nurses thought the pen did not deliver the complete dosage of insulin.A change of insulin therapy protocol was done by stopping tresiba.There was improvement of the glycaemia level following the change of "procotol".The patient went back to the initial protocol on (b)(6) 2018 with a pen brought by the parents.The product was then reintroduced without symptom.Then, he used prefilled pens.After a discussion with the nurses, they did not proceed to purge the pen with 2 units.The patient received a treatment for the event: potassium chloride orally + vichy water (non codable).Batch number was available.Action taken to novopen echo was reported as drug discontinued temporarily.On (b)(6) 2018 the outcome for the event "ketosis increased" was recovered.On (b)(6) 2018 the outcome for the event "hyperglycaemia" was recovered.The outcome for the event "hyperglycaemia" was not reported.The outcome for the event "did not deliver the complete dosage of insulin" was not reported.The outcome for the event "black piston rod of the pen was not in contact with the orange piston" was not reported.The outcome for the event "pen did not deliver the complete dosage of insulin" was not reported.This case was reclassified from a non serious case to a serious case on 02-nov-2018 due to the event of "hyperglycaemia" with seriousness criteria of "medically significant".Reporter comment: the hcps suspected a problem with the device and not the cartridge.The pharmacist thought that the nurses did not perform a flow test.No alternative aetiology.
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Case description: investigation results: name: novopen echo, batch number: gvgh235-7.The device was returned with the cartridge from this case mounted.On receipt there was a gap between piston rod of the device and the rubber piston in the cartridge, the piston rod was fully retracted.If the user attempted to make an air shot or to dose prior to this no insulin would have been dispensed.The user either retracted the piston rod correctly during change of the cartridge, but mounted a partly used cartridge afterwards without ensuring contact between the piston rod and the rubber piston by following the air shot procedure, the user left the needle on the pen between injections, or the user retracted the piston rod between injections.The electronic register was checked.No remarks.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The function of the piston rod is normal.The dose accuracy was measured by weighing.The product was found to be normal.The results were found to comply with specifications.Use a new needle for each injection.The needle should be mounted immediately before the injection.Always remove the used needle immediately after each injection and store the device without a needle attached.Otherwise, temperature fluctuations may cause leakage through the needle, resulting in a space between the rubber piston in the cartridge and the piston rod in the device.Furthermore, clogging of the needle may occur.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Since last submission, the case has been updated with the following: manufacturing comment has been updated.Investigational result updated.Narrative updated accordingly.Manufacturer's comment: upon investigation of returned novopen echo, there was a gap between piston rod of the device and the rubber piston in the cartridge, the piston rod was fully retracted.If the user attempted to make an air shot or to dose prior to this no insulin would have been dispensed.The device was tested with a new cartridge and to be functioning normally.The gap between the plunger and the piston rod could be the result of the user leaving the needle attached to the pen between injections and not checking the insulin flow before the injection as described in the ifu.This could contribute to the patient experiencing a hyperglycemic related event; however it cannot be ruled out that the cartridge was taken out of the pen and the piston rod returned into dosing mechanism before the sample was returned to novo nordisk for investigation evaluation summary name: novopen echo.Batch number: gvgh235-7.The device was returned with the cartridge from this case mounted.On receipt there was a gap between piston rod of the device and the rubber piston in the cartridge, the piston rod was fully retracted.If the user attempted to make an air shot or to dose prior to this no insulin would have been dispensed.The user either retracted the piston rod correctly during change of the cartridge, but mounted a partly used cartridge afterwards without ensuring contact between the piston rod and the rubber piston by following the air shot procedure, the user left the needle on the pen between injections, or the user retracted the piston rod between injections.The electronic register was checked.No remarks.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.The function of the piston rod is normal.The dose accuracy was measured by weighing.The product was found to be normal.The results were found to comply with specifications.Use a new needle for each injection.The needle should be mounted immediately before the injection.Always remove the used needle immediately after each injection and store the device without a needle attached.Otherwise, temperature fluctuations may cause leakage through the needle, resulting in a space between the rubber piston in the cartridge and the piston rod in the device.Furthermore, clogging of the needle may occur.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.
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