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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) fainting [syncope].Holder can no longer be unscrewed and the cartridge with new insulin cannot be inserted [device malfunction].Patient uses the dialling clicks to.Estimate the dose of the insulin [wrong technique in product usage process].Patient leaves the needle attached to the pen in between injections [wrong technique in product usage process].Case description: this serious spontaneous case from germany was reported by a consumer as "fainting(fainting)" with an unspecified onset date, "holder can no longer be unscrewed and the cartridge with new insulin cannot be inserted(device component malfunction)" with an unspecified onset date, "patient uses the dialling clicks to estimate the dose of the insulin(wrong technique in product usage process)" with an unspecified onset date, "patient leaves the needle attached to the pen in between injections(wrong technique in product usage process)" with an unspecified onset date, and concerned a elderly male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", patient's height: 168 cm patient's weight: 56 kg patient's bmi: 19.84126980.Current condition: type 1 diabetes mellitus.(duration not reported).On an unknown date, patient had a defective pen.In which it was not possible to insert the insulin cartridge because the holder can no longer be unscrewed and the cartridge with new insulin cannot be inserted it was already the 3rd pen with the same error within a very short time.Patient had fainted several times and woken up in hospital (hospitalization details not reported).And patient was not hospitalised.On an unknown date, patient reused the needles in emergency cases.On an unknown date, patient leaves the needle attached to the pen in between injections.On an unknown date, patient uses the dialling clicks to estimate the dose of the insulin.There are no recent changes in diet or physical exercise.Patient attached the needle to the pen in a 180 degree angle (straight on).There was no difference in force needed to inject feel different from normal.Patient did not store the insulin in use at room temperature 20 - 25 °c.Patient did not split the dose e.G.Change to another cartridge to get the intended dose, just before the event happened.There was no drop of the pen and observed leakage of insulin during the event.Batch number of novopen echo: not reported the outcome for the event "fainting(fainting)" was unknown.The outcome for the event "holder can no longer be unscrewed and the cartridge with new insulin cannot be inserted(device component malfunction)" was unknown.The outcome for the event "patient uses the dialling clicks to estimate the dose of the insulin(wrong technique in product usage process)" was not reported.The outcome for the event "patient leaves the needle attached to the pen in between injections(wrong technique in product usage process)" was not reported.References included: reference type: e2b company number reference id#: de-novoprod-982525 reference notes: reference type: bfarm report number reference id#: 31333/22 reference notes: additional reference no.Preliminary manufacturer's comment: 12-dec-2022: the suspected device novopen echo has not been returned to novonordisk for evaluation.No conclusion is reached.Reporter comment: patient year of birth 1938.

Event Description

Case description: investigational result: novopen echo : unknown batch.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following information: investigation result updated.Annex b, c, d and g codes updated.Narrative updated accordingly.Final manufacturer's comment: 06-jan-2023: the suspected device novopen echo has not been returned to novo nordisk and batch number is also unavailable.Batch trend analysis or reference sample analysis is not performed.With the limited available information, it is not possible to elucidate a clear root cause for functionality of novopen echo.Elderly age and medical history of long standing diabetes are assessed as risk factors for the reported event of syncope in the patient.However, information on clinical course leading to fainting, final diagnosis, relevant clinical and investigation results, associated diabetic complications if any are unavailable for thorough medical assessment.H3 continued: evaluation summary: novopen echo : unknown batch.No investigation was possible, because neither sample nor batch number was available.

• 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: 15982604
• MDR Text Key: 305492042
• Report Number: 9681821-2022-00102
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male
• Patient Weight: 56 KG