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

Model Number N/A

Device Problems Defective Component (2292); Inaccurate Delivery (2339)

Patient Problem Hypoglycemia (1912)

Event Date 09/05/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Big hypoglycemia [hypoglycaemia].The pen had changed on its own and injected 5.5 units instead of 2.5 units [incorrect dose administered by device].Defective product, the pen had changed on its own to 5.5 units.[device malfunction].Case description: this serious spontaneous case from france was reported by a pharmacist as "big hypoglycemia(hypoglycemia)" beginning on (b)(6) 2023, "the pen had changed on its own and injected 5.5 units instead of 2.5 units(incorrect dose administered by device)" beginning on (b)(6)2023, "defective product, the pen had changed on its own to 5.5 units.(device component malfunction)" with an unspecified onset date, and concerned a 7 years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index (bmi) was not reported.Current condition: diabetes(type and duration was not reported).Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml , tresiba penfill 100 u/ml(insulin degludec) solution for injection, 100 iu/ml.On (b)(6) 2023, the mother of a patient reported that during the injection, the nurse selected 2.5 units and at the moment of injection, the pen had changed on its own to 5.5 units.The patient therefore received a much greater injection than she needed and had a big hypoglycemia for which patient received sugar intake.The pharmacist assures us that it isn't the nurse who adjusted the pen to 5.5, but that it turned itself on its own although nurse had set it to 2.5.The pen has administered the wrong quantity of insulin.It was reported that the patient did not change the treatment for the last 3 month.It was not the first time that the patient was treated for this indication.The patient has never made this error before.The product was in the original packaging.No alternative aetiology was reported.Batch numbers: novopen echo: hvgl295.Action taken to novopen echo was reported as unknown.On (b)(6) 2023 the outcome for the event "big hypoglycemia(hypoglycemia)" was recovered.On (b)(6) 2023 the outcome for the event "the pen had changed on its own and injected 5.5 units instead of 2.5 units(incorrect dose administered by device)" was recovered.The outcome for the event "defective product, the pen had changed on its own to 5.5 units.(device component malfunction)" was not reported.

Event Description

Case description: this serious spontaneous case from france was reported by a pharmacist as "big hypoglycemia(hypoglycemia)" beginning on (b)(6) 2023, "the pen had changed on its own and injected 5.5 units instead of 2.5 units(incorrect dose administered by device)" beginning on (b)(6) 2023, "defective product, the pen had changed on its own to 5.5 units.(device component malfunction)" with an unspecified onset date, and concerned a 7 years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) (dose, frequency & route used- nurse selected 2.5 patient changed to 5.5, subcutaneous) from unknown start date for "drug use for unknown indication", tresiba penfill 100 u/ml (insulin degludec) (dose, frequency & route used- unk, subcutaneous) from unknown start date for "product used for unknown indication", batch numbers: novopen echo: hvgl295.Novorapid penfill: mr7jk03.Tresiba penfill 100 u/ml: asku.Action taken to novorapid penfill was not reported.Action taken to tresiba penfill 100 u/ml was not reported.On 05-sep-2023 the outcome for the event "big hypoglycemia(hypoglycemia)" was recovered.On 05-sep-2023 the outcome for the event "the pen had changed on its own and injected 5.5 units instead of 2.5 units(incorrect dose administered by device)" was recovered.The outcome for the event "defective product, the pen had changed on its own to 5.5 units.(device component malfunction)" was not reported.Since last submission, the following were updated: novorapid penfill and tresiba penfill were updated to suspects.Action taken was updated for novorapid penfill and tresiba penfill.Listedness was updated for novorapid penfill and tresiba penfill.Narrative was updated accordingly.

Event Description

Case description: investigation result: novopen echo rouge, batch number: hvgl295 the device was returned with the cartridge from this case mounted.A visual examination of the returned product was performed.Upon receipt of device the mounted penfill was under pressure, indicating an attempt to deliver insulin without any flow in the insulin delivery system (device/penfill/needle).The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.Nonconformity-related documentation was examined.No irregularities recorded and therefore no further action.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.The electronic register was checked.The readout revealed indications of unintended use of the pen.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.In this test the memory display mirrored all expelled dose sizes, selected by random, correctly.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic unit was examined.Nothing abnormal was detected.It was not possible to observe the alleged fault.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.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 is mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.Novorapid penfill batch number :unknown a visual examination of the returned product was performed.The returned cartridge was tested for delivery with a novopen® echo® and a novo nordisk needle.During testing it was possible to deliver preparation.It was not possible to test the cartridge for inaccuracy.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.Chemical analysis of the returned sample(s) was performed.The result was within acceptable limits.During examination of the product, no irregularities related to the complaint were detected.Tresiba penfill batch number :unknown 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 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: 26-dec-2023: the suspected device novopen echo has been returned to novo nordisk for evaluation.Upon preliminary examination, it was found that the mounted penfill was under pressure, indicating an attempt to deliver insulin without any flow in the insulin delivery system (device/penfill/needle).The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic unit was examined.Nothing abnormal was detected.It was not possible to observe the alleged fault.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.It indicates that the display is broken and should not be used again.It is possible that patient administered extra dose of insulin due to this display error resulting in hypoglycaemia.Events are listed.This single case report is not considered to change the current knowledge of thesafety profile of novorapid and tresiba.H3 continued: evaluation summary novopen echo rouge, batch number: hvgl295 the device was returned with the cartridge from this case mounted.A visual examination of the returned product was performed.Upon receipt of device the mounted penfill was under pressure, indicating an attempt to deliver insulin without any flow in the insulin delivery system (device/penfill/needle).The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.Nonconformity-related documentation was examined.No irregularities recorded and therefore no further action.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.The electronic register was checked.The readout revealed indications of unintended use of the pen.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.In this test the memory display mirrored all expelled dose sizes, selected by random, correctly.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic unit was examined.Nothing abnormal was detected.It was not possible to observe the alleged fault.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.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 is mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd,, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 18002773
• MDR Text Key: 326471379
• Report Number: 9681821-2023-00142
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: HVGL295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NOVORAPID PENFILL (INSULIN ASPART); TRESIBA PENFILL 100 U/ML (INSULIN DEGLUDEC)
• Patient Outcome(s): Other; Life Threatening
• Patient Age: 7 YR
• Patient Sex: Female