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

Model Number N/A

Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Date 03/16/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) he was sleepy at home for 2 hours following incident [somnolence] hypoglycaemia [hypoglycaemia] blood glucose measures 2.8 mmol [blood glucose decreased] pen dose button showed zero for first injection [device information output issue] he was injected twice at lunchtime [extra dose administered] case description: this serious spontaneous case from the united kingdom was reported by a nurse as "he was sleepy at home for 2 hours following incident(sleepy)" beginning on (b)(6) 2023, "hypoglycaemia(hypoglycaemia)" beginning on (b)(6) 2023, "blood glucose measures 2.8 mmol(blood glucose decreased)" beginning on (b)(6) 2023, "pen dose button showed zero for first injection(incorrect measurement by device)" with an unspecified onset date, "he was injected twice at lunchtime(extra dose administered)" with an unspecified onset date, and concerned a 7 years old male patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "type 1 diabetes", novorapid (insulin aspart) (dose, frequency & route used-1.50 units, subcutaneous) from (b)(6) 2023 and ongoing for "type 1 diabetes", patient's height, weight and body mass index not reported dosage regimens: novopen echo plus: novorapid: (b)(6) 2023 to not reported (dosage regimen ongoing); current condition: type 1 diabetes( since (b)(6) 2023) on (b)(6)2023, the patient had hypoglycemia which recovered on the same day.On an unknown date patient was given injection twice at lunchtime at school because pen dose button showed zero, data showed extra insulin.It was reported that classroom assistant had received training.She felt 1st dose had not been delivered as dose indicator read zero, so they injected a second dose.On (b)(6) 2023, patient's blood glucose measures 2.8 mmol and the patient was sleepy at home for 2 hours following incident.Batch numbers: novopen echo plus: mvg6f16 novorapid: asku action taken to novopen echo plus was not reported.Action taken to novorapid was reported as no change.On (b)(6) 2023 the outcome for the event "he was sleepy at home for 2 hours following incident(sleepy)" was recovered.On (b)(6) 2023 the outcome for the event "hypoglycaemia(hypoglycaemia)" was recovered.On (b)(6) 2023 the outcome for the event "blood glucose measures 2.8 mmol(blood glucose decreased)" was recovered.The outcome for the event "pen dose button showed zero for first injection(incorrect measurement by device)" was unknown.The outcome for the event "he was injected twice at lunchtime(extra dose administered)" was recovered.Company comment: somnolence is assessed as unlisted event; hypoglycaemia and blood glucose decreased are assessed as listed events according to the novo nordisk current ccds in novorapid.Patient developed somnolence due to hypoglycaemia, which in turn is due to extra dose administered.This single case report is not considered to change the current knowledge of the safety profile of novorapid.

Event Description

Case description: on (b)(6) 2023: the final report date has been updated since investigation results and imdrf codes of novopen echo plus are still under investigation.Since last submission following information updated -final report date updated in eu/ca device tab -narrative updated.

Event Description

Investigation result: name: novopen echo® plus red, batch number: mvg6f16 a visual examination of the returned product was performed.The batch documentation was reviewed and found to be normal.Nonconformity-related documentation was examined.No irregularities recorded and therefore no further action.No abnormalities relating to the observed problem were found.The electronic register was checked.No remarks.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.It was not possible to detect the alleged fault.The memory display was found to be normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Name: novorapid®, batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission following information updated investigation result added imdrf code added relevant fields updated in eu/ca tab narrative updated accordingly company comment: somnolence is assessed as unlisted event; hypoglycaemia and blood glucose decreased are assessed as listed events according to the novo nordisk current ccds in novorapid.Patient developed somnolence due to hypoglycaemia, which in turn is due to extra dose administered.The suspected device was found to function normally as intended, no abnormalities detected.This single case report is not considered to change the current knowledge of the safety profile of novorapid.Final manufacturer's comment: 11-jul-2023: the suspected device novopen echo plus has been returned to novo nordisk for evaluation.Upon investigation, device was found to be working as intended, no abnormalities detected.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.Since no faults were found on the returned device novopen echo plus and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse events.Somnolence could be related to hypoglycaemia due to extra dose administered.Continued: evaluation summary name: novopen echo® plus red, batch number: mvg6f16 a visual examination of the returned product was performed.The batch documentation was reviewed and found to be normal.Nonconformity-related documentation was examined.No irregularities recorded and therefore no further action.No abnormalities relating to the observed problem were found.The electronic register was checked.No remarks.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.It was not possible to detect the alleged fault.The memory display was found to be normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

Event Description

Case description: case re-submitting as reportable final.Previously the case was submitted as final non-reportable incident.04-dec-2023; based on the '(b)(4) document (b)(6) 2023', an update was made on handling 'undesirable side effects'.This case was retrospectively reconciled where the case with unlisted event should be submitted as final reportable incident.Now the case was performed with necessary corrections and will be submitted with a delayed report.

• Brand Name: NOVOPEN ECHO PLUS
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd,, ; 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: 16796352
• MDR Text Key: 313835815
• Report Number: 9681821-2023-00059
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/21/2024
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: MVG6F16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 06/12/2023; 07/06/2023; 07/06/2023
• Supplement Dates FDA Received: 07/07/2023; 08/01/2023; 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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
• Patient Outcome(s): Other
• Patient Age: 7 YR
• Patient Sex: Male