MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Break (1069); Fracture (1260); Defective Component (2292); No Flow (2991); Device Handling Problem (3265)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim: patient random extremely rapid hypos; hypoglycaemia.Novopen echo has broken; device breakage.Screw wasn't moving; device malfunction.When she gave her insulin no insulin went in device failure.Then nights blood glucose was rising blood glucose increased.Patient has syringes to administer her insulin in the mean time wrong technique in product usage process.Patient recovered by changing to another batch product quality issue.Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "patient random extremely rapid hypos(hypoglycemia)" with an unspecified onset date, "novopen echo has broken(device breakage)" with an unspecified onset date, "screw wasn't moving(device component malfunction)" with an unspecified onset date, "when she gave her insulin no insulin went in(device failure)" with an unspecified onset date, "then nights blood glucose was rising(blood glucose increased)" with an unspecified onset date, "patient has syringes to administer her insulin in the mean time(inappropriate drug extraction with syringe)" with an unspecified onset date, "patient recovered by changing to another batch(product lot specific issue)" with an unspecified onset date, and concerned a 21 years old female patient who was treated with levemir penfill (insulin detemir) solution for injection,.0024 mol/l (dose, frequency & route used - x2 daily injections, unknown) from unknown start date for "type 1 diabetes mellitus", , novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes".Patient's height, weight, and body mass index were not reported.Dosage regimen of levemir penfill and novopen echo: were not reported.Current condition: type 1 diabetes mellitus (duration not reported).On an unknown date, patient had random extremely rapid hypos occurred twice with blood sugars to 1.5 mmol/l.No treatment received.Have recovered by changing to another batch.I tried 2 vials from that batch and they were both as described above.On an unknown date, patient had random very quick blood glucose drops.Patient was very good at control.Levemir seemed to work one day, but not the next.Then nights i was rising, despite doing x2 the normal dose.Other nights i dropped on the exact same dose.It was reported that, the suspect product was working one day, but not the next day.Some days seemed ok, others were as if there was no levemir.The reason for levemir behaving that way was not reported to be due to the drug.Patient advised that, novopen echo has broken and thought that giving dose of insulin but the screw wasn't moving.Caller advised that the air shot and the insulin was coming out but when patient gave insulin no insulin went in.Patient has syringes to administer insulin in the mean time.Batch number of levemir penfill and novopen echo were not available action taken to levemir penfill was reported as product discontinued.The outcome for the event "patient random extremely rapid hypos(hypoglycemia)" was recovered.The outcome for the event "novopen echo has broken(device breakage)" was not reported.The outcome for the event "screw wasn't moving(device component malfunction)" was not reported.The outcome for the event "when she gave her insulin no insulin went in(device failure)" was not reported.The outcome for the event , "then nights blood glucose was rising(blood glucose increased)" was not reported.The outcome for the event, "patient has syringes to administer her insulin in the mean time(inappropriate drug extraction with syringe)" was not reported.The outcome for the event "patient recovered by changing to another batch(product lot specific issue)" was not reported.Since last submission the following has updated: suspect "novopen echo" added.Annex a,e,f coded added.New events, "device breakage, device component malfunction, device failure, inappropriate drug extraction with syringe." added narrative updated accordingly.References included: reference type: e2b company number.Reference id#: (b)(4); reference notes: preliminary manufacturer's comment: on 11-dec-2020: the suspected device novopen echo has not been returned to novo nordisk for evaluation.Relevant information on needle re-usage, storage of devices and proper injection technique are unavailable for complete evaluation.Considering the nature of technical complaints (device broken), it could be related to product handling error.No conclusion has been reached.Additional dosage regimens; suspect product.Dose, frequency & route used 3.#1 levemir penfill regimen #2.Unk.(another batch), unknown.#1 levemir penfill regimen #3.X2 the normal dose (dose increased), unknown.

Event Description

Case description: since last submission the following has updated: annex a,e, f codes updated.Other relevant history updated.

Event Description

(related symptoms if any separated by commas).Patient random extremely rapid hypos [hypoglycaemia].Novopen echo has broken [device breakage].Screw wasn't moving [device malfunction].When she gave her insulin no insulin went in [device failure].Then nights blood glucose was rising [blood glucose increased].Patient has syringes to administer her insulin in the mean time [wrong technique in product usage process].The patient stores the device with the needle attached [product storage error].Patient recovered by changing to another batch [product quality issue].Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "patient random extremely rapid hypos (hypoglycemia)" with an unspecified onset date, "novopen echo has broken (device breakage)" with an unspecified onset date, "screw wasn't moving (device component malfunction)" with an unspecified onset date, "when she gave her insulin no insulin went in (device failure)" with an unspecified onset date, "then nights blood glucose was rising (blood glucose increased)" with an unspecified onset date, "patient has syringes to administer her insulin in the mean time(inappropriate drug extraction with syringe)" with an unspecified onset date, "the patient stores the device with the needle attached(device stored with needle attached)" with an unspecified onset date, "patient recovered by changing to another batch (product lot specific issue)" with an unspecified onset date, and concerned a 21 years old female patient who was treated with levemir penfill (insulin detemir) from unknown start date for "type 1 diabetes mellitus", novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus".It was reported that the patient does not change the needle after every injection and the brand of needle used by patient was bd medical (4mm).The patient stores the device with the needle attached.Batch numbers: levemir penfill: asku.Novopen echo: gvgd991.Action taken to levemir penfill was reported as product discontinued.The outcome for the event "the patient stores the device with the needle attached(device stored with needle attached)" was not reported.Investigations results: novopen echo batch number: gvgd991.A visual examination of the returned product was performed.Paint from the pen has smudged onto the dosage selector.The fault has not influence on the functions of the pen.The fault was caused by an error in novo nordisk a/s.The electronic register was checked.Several mitigation codes were present, but not related to deliver of drug.Visual examination and functional testing 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 dose accuracy was measured by weighing.The results were found to comply with specifications.The product was found to be normal and it not broken.The memory display showed (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.Investigations results: levemir penfill: no investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission the following has updated: batch number updated, device information updated, inv updated, a,b,c,d,g coded updated, new event "device stored with needle attached" added, narrative updated accordingly.On 18-dec-2020, the case has missed to notify for the follow up (on (b)(6) 2020) and later on it was identified and hence filed tle.Final manufacturer's comment: 19-jan-2021: upon investigation of the returned novopen echo, it was found that paint from the pen has smudged onto the dosage selector.The fault has not influence on the functions of the pen.The product was found to be normal and it not broken.The memory display showed (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.The user can detect the fault and will abstain from further use of the display functionality.The user can still use the pen and it is judged that the fault has no impact on the patient's health or treatment.H3: continued: evaluation summary: novopen echo batch number: gvgd991.A visual examination of the returned product was performed.Paint from the pen has smudged onto the dosage selector.The fault has not influence on the functions of the pen.The fault was caused by an error in novo nordisk a/s.The electronic register was checked.Several mitigation codes were present, but not related to deliver of drug.Visual examination and functional testing 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 dose accuracy was measured by weighing.The results were found to comply with specifications.The product was found to be normal and it not broken.The memory display showed (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11031865
• MDR Text Key: 223374788
• Report Number: 9681821-2020-00064
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2019
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: GVGD991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR