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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Clicked to 16units however pen gave 20.5 units [incorrect dose administered by device].Drug overdose as pen injected 20.5 units instead of 16 units [overdose].Fiasp was advised to take in im route [product prescribing error].Case description: this serious spontaneous case from the united kingdom was reported by a other health care professional as "clicked to 16units however pen gave 20.5 units(incorrect dose administered by device)" beginning on (b)(6) 2023, "drug overdose as pen injected 20.5 units instead of 16 units(drug overdose)" beginning on (b)(6) 2023, "fiasp was advised to take in im route(drug route prescribing error)" with an unspecified onset date, and concerned a 35 years old female patient who was treated with novopen (insulin delivery device) from unknown start date for "type 1 diabetes", fiasp (insulin aspart) (dose, frequency & route used-unk (as per carb counting), intramuscular) from unknown start date for "type 1 diabetes".Current condition: type 1 diabetes (duration not reported carb counting).Historical condition: para 2 (following an emergency c/section).Procedure: emergency c/section.On an unknown date patient was using novopen for administration of fiasp.Patient carb counting with ratio.Physician prescribed to 16 units of fiasp to take in intramuscular route to cover the meal.Patient was to administer the same, on (b)(6) 2023 patient noted on administration that pen had administered 20.5 units.Type of injury reported as : near miss.Details of incident: did not administering correct dose, clicked to 16units however pen gave 20.5 units action taken: patient administered fiasp at bedside, on completion of injection patient noted pen had administered 20.5 units.Endocrine consultant obstetrics informed and plan in place.Batch numbers of fiasp and novopen were not reported.Action taken to novopen was not reported.Action taken to fiasp was not reported.The outcome for the event "clicked to 16units however pen gave 20.5 units(incorrect dose administered by device)" was recovered.The outcome for the event "drug overdose as pen injected 20.5 units instead of 16 units(drug overdose)" was recovered.The outcome for the event "fiasp was advised to take in im route(drug route prescribing error)" was not reported.References included: reference type: mhra report number.Reference id#: id (b)(4) mhra (b)(4).Reference notes: mhra (medicines and healthcare products regulatory agency).Reference type: e2b report duplicate.Reference id#:(b)(4).Reference notes: northern ireland adverse incident centre (niaic).

Event Description

Case description: this serious spontaneous case from the united kingdom was reported by a other health care professional as "clicked to 16units however pen gave 20.5 units(incorrect dose administered by device)" beginning on (b)(6) 2023, "drug overdose as pen injected 20.5 units instead of 16 units(drug overdose)" beginning on (b)(6) 2023, "fiasp was advised to take in im route(drug route prescribing error)" with an unspecified onset date, and concerned a 35 years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", , fiasp (insulin aspart) from unknown start date for "type 1 diabetes mellitus", batch numbers: novopen echo: unknown; fiasp: mr7ec46.Action taken to novopen echo was not reported.Since last submission the case has been updated with the following(not yet submitted): suspect product updated from novopen to novopen echo; batch numbers of suspects updated; eu/ca device tab updated; narrative has been updated accordingly.References included: reference type: mhra report number.Reference id#: (b)(4).Reference notes: mhra (medicines and healthcare products regulatory agency).Reference type: e2b report duplicate.Reference id#: (b)(4).Reference notes: northern ireland adverse incident centre (niaic).Reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2023-00061.Reference notes: medwatch 3500a mfr.Report number.

Event Description

Case description: investigational result: name: novopen echo, batch number: lvg3v44 the device was returned with the cartridge from this case mounted.Visual examination and functional testing were performed.Foreign dry matter observed on internal or external pen parts, e.G., dust, dirt, or dried liquid stains.The observed problem was not related to any novo nordisk processes and it was a result of accidental damage during use of the device.The painted surface of the pen was damaged, and the paint was swollen and/or flaking off.The fault was caused by accidental damage during use of the device.The pen surface was worn.Scratches or dents in pen surfaces, or wear on printed or engraved figures on the pen surface caused by normal or rough use of the device.The fault had no impact on the mechanical functions of the pen.The electronic register was checked.No remarks.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 using a random cartridge.The product was found to be normal.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Name: fiasp penfill, batch number: mr7ec46 a visual examination of the returned product was performed.It was not possible to test the cartridge for inaccuracy.Due to insufficient complaint sample material no further investigation was performed.It was not possible to investigate the returned sample comprehensively.A reference sample was examined macroscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.Since last submission the case has been updated with the following - investigation result updated -narrative updated accordingly.Final manufacturer's comment: 23-jun-2023: one used novopen echo with cartridge mounted has been returned for investigation.Foreign dry matter noted on cartridge holder, small scratched on window and paint peeling noted.The fault is caused by accidental damage during use of the device.The fault has no impact on the mechanical functions of the pen.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 product was found to be normal.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Continued: evaluation summary name: novopen echo, batch number: lvg3v44 the device was returned with the cartridge from this case mounted.Visual examination and functional testing were performed.Foreign dry matter observed on internal or external pen parts, e.G., dust, dirt, or dried liquid stains.The observed problem was not related to any novo nordisk processes and it was a result of accidental damage during use of the device.The painted surface of the pen was damaged, and the paint was swollen and/or flaking off.The fault was caused by accidental damage during use of the device.The pen surface was worn.Scratches or dents in pen surfaces, or wear on printed or engraved figures on the pen surface caused by normal or rough use of the device.The fault had no impact on the mechanical functions of the pen.The electronic register was checked.No remarks.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 using a random cartridge.The product was found to be normal.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

• 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, MEDICAL SYSTEMS; brennum park; hilleroed,, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 16807247
• MDR Text Key: 313925002
• Report Number: 9681821-2023-00061
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: LVG3V44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female