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

Model Number N/A

Device Problems Mechanical Jam (2983); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose value of 500mg/dl for two days [blood glucose increased].Novopen echo plus pen is stuck [device mechanical issue].No insulin is coming out [device failure].Case description: this serious spontaneous case from spain was reported by a pharmacist as "blood glucose value of 500mg/dl for two days(blood glucose increased)" with an unspecified onset date, "novopen echo plus pen is stuck(device mechanical jam)" with an unspecified onset date, "no insulin is coming out(device failure)" with an unspecified onset date, and concerned a 61 years old female patient who was treated with novopen echo plus (insulin delivery device) from unknown start date for "device therapy", fiasp (insulin aspart) (dose, frequency & route used-unk) from unknown start date for "product used for unknown indication", patient's height, weight and body mass index not reported medical history was not provided.On an unknown date, patient had a blood glucose (blood glucose) value of 500mg/dl for two days, as the novopen echo plus pen was stuck and no insulin (fiasp penfill) was coming out.The patient tried changing three different cartridges, as well as the needles and insulin still did not come out.It was reported that the patient will take the pen to the pharmacy for collection and replacement batch numbers: novopen echo plus: mvg6j36, fiasp: requested.Action taken to novopen echo plus was not reported.Action taken to fiasp was not reported.The outcome for the event "blood glucose value of 500mg/dl for two days(blood glucose increased)" was not reported.The outcome for the event "novopen echo plus pen is stuck(device mechanical jam)" was not reported.The outcome for the event "no insulin is coming out(device failure)" was not reported.Reporter comment: recibimos llamada de paciente, indica que lleva dos días con un valor de glucemia de 500 mg/dl, ya que la pluma novopen echo plus está atascada y no sale insulina (fiasp penfill).Ha probado a cambiar tres cartuchos diferentes, así como las agujas y la insulina sigue sin salir.Insulina: fiasp penfill.Número do lote: mvg6j36, id: penaamdax.La paciente llevará la pluma a la farmacia para su recogida y reposición.Paciente es una mujer, 61 años, león.

Event Description

Case description: investigational result: name: novopen echo plus, batch number: mvg6j36 name: novopen echo plus, batch number: mvg6j36 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.Several codes in the logs indicates that the pen has been used with a broken or blocked needle.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 results were found to comply with specifications.The product was found to be normal.Confirmed 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 "error" 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.Name: fiasp batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission, the following information updated, - investigation result was updated - imdrf codes were added, - device related fields were updated.Final manufacturer's comment: 27-feb-2024: the suspected device novopen echo plus has been returned to novo nordisk for evaluation.Upon investigation, device was found to be functioning normally, as per the specifications.During examination of the product, no irregularities related to the complaint were 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 memory data in the device suggests that device used with blocked needle.There are no fault or malfunction on the pen.The electronic display is warning the patient that he/she is using the pen wrongly as the patient is injecting with a blocked needle attached.The patient will not receive any insulin and could experience a hyperglycaemic event.Continued: evaluation summary name: novopen echo plus, batch number: mvg6j36 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.Several codes in the logs indicates that the pen has been used with a broken or blocked needle.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 results were found to comply with specifications.The product was found to be normal.Confirmed 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 "error" 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.

• 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: 18666076
• MDR Text Key: 334833705
• Report Number: 9681821-2024-00027
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: SP
• PMA/PMN Number: K123766N/A
• 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
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/12/2024
• Device Model Number: N/A
• Device Lot Number: MVG6J36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2022
• 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: 61 YR
• Patient Sex: Female