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| Model Number N/A |
| Device Problem
Inaccurate Delivery (2339)
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| Patient Problems
Hyperglycemia (1905); Hypoglycemia (1912)
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| Event Date 06/01/2023 |
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Event Type
Injury
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Event Description
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Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia [hyperglycaemia].Hypoglycemia [hypoglycaemia].The drop of injector is twice bigger than the drop from the pen [device delivery system issue].Case description: this serious spontaneous case from russian federation was reported by a consumer as "hyperglycemia(hyperglycemia)" beginning on (b)(6) 2023, "hypoglycemia(hypoglycemia)" beginning on (b)(6) 2023, "the drop of injector is twice bigger than the drop from the pen(inaccurate delivery by device)" beginning on (b)(6) 2023, and concerned a 8 years old female patient who was treated with novopen echo (insulin delivery device) from (b)(6)2023 for "type 1 diabetes mellitus".Patient's height: 136 cm.Patient's weight: 21.5 kg.Patient's bmi: 11.62413490.Dosage regimens: novopen echo:(b)(6) 2023; current condition: type 1 diabetes mellitus (b)(6) 2022), reflux esophagitis, chronic gastritis, postinjection colitis, gastrointestinal allergy(gluten intolerance), functional disorders of the biliary tract, reactive changes in the pancreas procedure: 2 planned hospitalization (since onset of diabetes).Concomitant products included - fiasp flexpen (insulin aspart) solution for injection, 100 iu/ml 11/--/2022 to ongoing.As per the discharge summary patient's hba1c level was 6.5% and glycemia limits was between 5-10 mmol/l.There was no complications of diabetes.After which in gastroenterologist's examination patient was diagnosed with reflux esophagitis, chronic gastritis, postinjection colitis, gastrointestinal allergy (gluten intolerance-?), functional disorders of the biliary tract, reactive changes in the pancreas.Concomitant products included - fiasp flexpen(insulin aspart).From an unspecified date, since 2 month patient was using novopen echo and almost immediately the patient's blood glucose started jumping, from low to high.Patient experienced hypoglycemia and hyperglycemia.Patient felt numbness of lips, disorientation.At the beginning patient's mother didn't suspect the defect of the injector.But once patient's mother performed the experiment to check the workability of injector and compare the drop of insulin coming out from injector novopen echo and fiasp flexpen, patient's mother found that the drop of injector is twice bigger than the drop from the pen.It was reported that consumer did all according to patient leaflet: used new needle, did flow check and finally injected the same amount of insulin.' it was reported that during hyperglycemia caregiver gave additional shots of insulin and during hypoglycemia caregiver gave the patient sugar-containing products (juice, sweet tea etc).And as patient felt bad (according to the words of patient's mother), had confusion.Patient didn't lose consciousness but was close to pass out.So, patient couldn't recover without any help of caregiver.Patient blood glucose(blood glucose) was 5-10 mmol/l and hba1c(glycosylated haemoglobin) of 6.5%.As per the libre app, on (b)(6) 2023, patient's blood glucose value were 3.1 mmol/l, 16.9 mmol/l, 9.5 mmol/l, 2.5 mmol/l.On (b)(6) 2023, patient's blood glucose value were 15.6 mmol/l, 13.4 mmol/l, 9.8 mmol/l, 4.8 mmol/l, 5.7 mmol/l, 3.2 mmol/l, 3.5 mmol/l, 14.2 mmol/l , 14.3 mmol/l.On (b)(6) 2023, patient's blood glucose value were 7.9 mmol/l, 15.1 mmol/l, 3.8 mmol/l, 4.1 mmol/l, 3.6 mmol/l, 14.1 mmol/l, 16.1 mmol/l, 2.8 mmol/l , 9,2 mmol/l.On (b)(6) 2023, patient's blood glucose value 2.8 mmol/l, 2.7 mmol/l, 2.7 mmol/l, 3 mmol/l, 4.3 mmol/l , 2.9 mmol/l, 2.2 mmol/l , 3.1 mmol/l, 11.5 mmol/l, 16.9 mmol/l, 22.4 mmol/l, 24.7 mmol/l, 11.8 mmol/l, 5.9 mmol/l , 3.5 mmol/l, 3.1 mmol/l , 4.0 mmol/l, 6.6 mmol/l , 7.6 mmol/l.On (b)(6) 2023, patient's blood glucose value were 2.4 mmol/l, 2.6 mmol/l, 17.9 mmol/l, 18.9 mmol/l , 2.7 mmol/l, 2.2 mmol/l , 18.4 mmol/l , 19.1 mmol/l.Batch numbers: novopen echo: mvg7m77-2.The outcome for the event "hyperglycemia(hyperglycemia)" was not yet recovered.The outcome for the event "hypoglycemia(hypoglycemia)" was not yet recovered.The outcome for the event "the drop of injector is twice bigger than the drop from the pen(inaccurate delivery by device)" was not recovered.Preliminary manufacturer's comment: (b)(6) 2023: the suspected device has not been returned to novonordisk for evaluation.No conclusion is reached.
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Event Description
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Case description: investigational result: novopen® echo®, batch number: mvg7m77-2 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.No complaint sample was received for investigation; however, pictures were received.The pictures were examined but no conclusive investigation could be made based on them.Since last submission the case has been updated with the following: investigation result added imdrf code added relevant fields updated in eu/ca tab narrative updated accordingly final manufacturer's comment: 11-sep-2023: the suspected device novopen echo has not been returned to novo nordisk for investigation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen echo.Patient is 8-year-old kid with history of type 1 diabetes mellitus, which is considered as confounding factors for the development of hyperglycaemia and hypoglycaemia.Continued: evaluation summary investigational result novopen® echo®, batch number: mvg7m77-2 the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.No complaint sample was received for investigation; however, pictures were received.The pictures were examined but no conclusive investigation could be made based on them.
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Event Description
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Case description: patient did not felt any force in application and not used in clicks.Patient hadn't had any changes in diet or exercise level.Needle was properly attached and the product was stored correctly.Patient did not injected the dose into the area of skin with lumps.Patient did not have concomitant medications or endocrine diseases.As consumer set the dose 1 iu instead of 0.5 iu, patient should take some more carbohydrates (juice, sweet beverages).Reporter and patient were taught/trained how to use and completed the diabetes school patient blood glucose (blood glucose) was 5-10 mmol/l and hba1c (glycosylated haemoglobin) of 6.5% before the event.On (b)(6) 2023, patient's blood glucose (blood glucose) value were 3.1 mmol/l, 16.9 mmol/l, 9.5 mmol/l, 2.5 mmol/l (as per the libre app).On (b)(6) 2023, patient's blood glucose (blood glucose) value were 15.6 mmol/l, 13.4 mmol/l, 9.8 mmol/l, 4.8 mmol/l, 5.7 mmol/l, 3.2 mmol/l, 3.5 mmol/l, 14.2 mmol/l , 14.3 mmol/l.On (b)(6) 2023, patient's blood glucose (blood glucose) value were 7.9 mmol/l, 15.1 mmol/l, 3.8 mmol/l, 4.1 mmol/l, 3.6 mmol/l, 14.1 mmol/l, 16.1 mmol/l, 2.8 mmol/l , 9,2 mmol/l.On (b)(6) 2023, patient's blood glucose (blood glucose) value 2.8 mmol/l, 2.7 mmol/l, 2.7 mmol/l, 3 mmol/l, 4.3 mmol/l , 2.9 mmol/l, 2.2 mmol/l , 3.1 mmol/l, 11.5 mmol/l, 16.9 mmol/l, 22.4 mmol/l, 24.7 mmol/l, 11.8 mmol/l, 5.9 mmol/l , 3.5 mmol/l, 3.1 mmol/l , 4.0 mmol/l, 6.6 mmol/l , 7.6 mmol/l.On (b)(6) 2023, patient's blood glucose (blood glucose) value were 2.4 mmol/l, 2.6 mmol/l, 17.9 mmol/l, 18.9 mmol/l , 2.7 mmol/l, 2.2 mmol/l , 18.4 mmol/l , 19.1 mmol/l.On (b)(6) 2023, patient's blood glucose (blood glucose) value was 2.2 mmol/l (as per the libre app).Action taken of novopen echo was not reported.The outcome for the event "hyperglycemia(hyperglycemia)" was not recovered.The outcome for the event "hypoglycemia(hypoglycemia)" was not recovered.Since last submission the case has been updated with the following: trained user was ticked as yes.References included: reference type: e2b company number; reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#; reference id#: (b)(4); reference notes: medwatch 3500a mfr.Report number.
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Event Description
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Case description: the outcome for the event "hyperglycemia(hyperglycemia)" was recovered.The outcome for the event "hypoglycemia(hypoglycemia)" was recovered.Since last submission the case has been updated with the following: -event outcome updated for hyperglycemia and hypoglycemia -narrative updated accordingly.
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Event Description
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Case description: investigational result: novopen echo, batch number: mvg7m77-2 a visual examination of the returned product was performed.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.- the electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.Visual examination and functional testing were performed and 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 dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection the pen will function as normal again if a new injection needle was mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.Since last submission the case has been updated with the following: inv results were updated.Narrative updated accordingly final manufacturer's comment: 19-jan-2024: the suspected device novopen echo has been returned to novo nordisk for investigation.On preliminary examination, device was found to function normally and comply with specifications.The memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.The observed problem is caused by unintended use of the device.It is possible that patient administered extra dose of insulin due to this display error resulting in hypoglycaemia.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.Patient is 8-year-old kid with history of type 1 diabetes mellitus, which is considered as confounding factors for the development of hyperglycaemia and hypoglycaemia.H3 continued: evaluation summary investigational result novopen echo, batch number: mvg7m77-2 a visual examination of the returned product was performed.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.Visual examination and functional testing were performed and 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 dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection the pen will function as normal again if a new injection needle was mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.
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