MAUDE Adverse Event Report: NOVOPEN ECHO; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Defective Component (2292); Defective Device (2588); Mechanical Jam (2983)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).The needle and the pen were stuck in her skin after a vacuum had been created [injury associated with device].The piston did not return to its proper position and the pen unlocks on its own [device malfunction].This serious spontaneous case from greece was reported by a consumer as "the needle and the pen were stuck in her skin after a vacuum had been created(injury associated with device)" with an unspecified onset date, "the piston did not return to its proper position and the pen unlocks on its own(device malfunction)" with an unspecified onset date, and concerned a female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", novofine 4mm (32g) (needle) from unknown start date for "type 1 diabetes mellitus".Current condition: type 1 diabetes mellitus.Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml.On an unknown date, while the patient was administering dose of novorapid penfill with novopen echo, the needle and the pen were stuck in skin after a vacuum had been created.They had to go to the outpatient department of the hospital to have it removed.The doctor who removed it explained that it stuck because the piston did not return to its proper position.It was also reported that the novopen echo was stored at the refridgerator (2-8 celsius degrees) due to high temperature during summer and the patient had observed that the pen unlocked on its own.Batch number of novopen echo and novofine 4mm (32g) was requested.Action taken to novopen echo was reported as product discontinued.Action taken to novofine 4mm (32g) was not reported.The outcome for the event "the needle and the pen were stuck in her skin after a vacuum had been created(injury associated with device)" was recovered.The outcome for the event "the piston did not return to its proper position and the pen unlocks on its own(device malfunction)" was recovered.Preliminary manufacturer's comment: 12-jul-2021: the suspected device (novopen echo) and novofine needle has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigation results: suspect product: novopen echo, 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.Suspect product: novofine, 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 was updated with the following: -investigation results updated.-b,c, d, g codes were added.-narrative updated accordingly.Final manufacturer's comment: novopen echo.(b)(6) 2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.Batch number of device is not available, batch trend analysis or reference sample analysis was not performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause in relation to functionality of novopen echo.Considering the nature of the event, injury associated with device could be related product handling error.Final manufacturer's comment: novofine needles.(b)(6) 2021: the suspected device novofine needles has not been returned to novo nordisk for evaluation.Batch number of device is not available, batch trend analysis or reference sample analysis was not performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause in relation to functionality of novofine needles.Considering the nature of the event, injury associated with device could be related product handling error.H3 continued: evaluation summary suspect product: novopen echo, 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.

Event Description

Case description: it was reported that the patient was not in general reuse the needles also, the force needed to inject did not feel different from normal batch number of novopen echo was jvgt271.Since last submission, the case was updated with the following: batch number of novopen echo updated; device narrative updated; narrative updated accordingly.

Event Description

Novopen echo - batch jvgt271.A visual examination of the returned product was 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 function of the piston rod was found normal.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.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.The memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.Suspect product: novofine, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case was updated with the following: --investigation result updated.-device tab, device addendunm tab updated.-narrative updated accordingly.Final manufacturer's comment: novopen echo.26-oct-2021: the suspected device novopen echo has been returned to novo nordisk for evaluation.And investigation of the device showed that it was working in accordance to specifications.However, the memory data in the device revealed that an attempted injection did not turn out to be successful.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.Considering the nature of the event, injury associated with device could be related product handling error.Final manufacturer's comment: novofine needles.03-sep-2021: the suspected device novofine needles has not been returned to novo nordisk for evaluation.Batch number of device is not available, batch trend analysis or reference sample analysis was not performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause in relation to functionality of novofine needles.Considering the nature of the event, injury associated with device could be related product handling error.H3 continued: evaluation summary: investigation results: novopen echo - batch jvgt271.A visual examination of the returned product was 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 function of the piston rod was found normal.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.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.The memory display showed - - (two lines) after injection.The observed problem does not influence the mechanical functions of the pen.The observed problem was caused by interference from foreign matter entering the pen and is due to accidental handling during use.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• MDR Report Key: 12195435
• MDR Text Key: 262420765
• Report Number: 9681821-2021-00038
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2021
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: JVGT271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Date Manufacturer Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOVORAPID PENFILL (INSULIN ASPART).; NOVORAPID PENFILL (INSULIN ASPART)
• Patient Outcome(s): Required Intervention