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

Model Number N/A

Device Problems Failure to Deliver (2338); Positioning Problem (3009)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

High blood sugar levels (up to 30mmol/l) [blood glucose increased] when pressing the pushbutton, he did not believe piston rod would move forward completely [device malfunction].Case description: this serious spontaneous case from australia was reported by a consumer as "high blood sugar levels (up to 30mmol/l) (blood glucose increased)" with an unspecified onset date, "when pressing the pushbutton, he did not believe piston rod would move forward completely(device component malfunction)" with an unspecified onset date, and concerned a male patient who was treated with novopen echo (insulin delivery device) from unknown start date and ongoing for "device therapy", the patient's height, weight and body mass index was not reported.Medical history was not provided.On an unspecified date, the patient believed piston rod would not move forward completely when pressing the push button.Patient believed that as he had high blood sugar levels occasionally (of up to 30mmol/l).Batch numbers of novopen echo was not available.Action taken to novopen echo was reported as no change.The outcome for the event "high blood sugar levels (up to 30mmol/l) (blood glucose increased)" was recovered.The outcome for the event "when pressing the pushbutton, he did not believe piston rod would move forward completely(device component malfunction)" was not reported.No further information available.Preliminary manufacturer's comment: 13-aug-2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigation result; novopen echo red - batch unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following: -investigation result updated -device tab, eu/ca tab and device addendum tab updated.Narrative updated accordingly final manufacturer's comment: 27-sep-2021: the suspected device (novopen echo) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available, no batch trend analysis or reference sample analysis performed.No confounding factors identified.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen echo.H3 continued: evaluation summary: investigation result; novopen echo red - batch unknown.No investigation was possible, because neither sample nor batch number was available.

Event Description

Case description: batch numbers of novopen echo was fvg8415-1.Since last submission, the case has been updated with the following: batch number of novopen echo updated, device available for manufacturer updated, narrative updated accordingly.Final manufacturer's comment: 13-jan-2022: the suspected device (novopen echo) has been returned to novo nordisk a/s for the investigation.Batch number of device reported.Investigation is ongoing, no conclusion is reached.

Event Description

Case description: investigational result: name: novopen echo red, batch number: fvg8415-1.A visual examination of the returned and functional testing were performed.Foreign dry matter observed on internal or external pen parts e.G., dust, dirt, or dried stains after a liquid.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 electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.The function of the piston rod was found to be normal.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.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 two lines (- -) or 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.Since last submission, the case has been updated with the following: - imdrf codings updated.- investigational result updated.- narrative updated accordingly.Final manufacturer's comment: 15-feb-2022: the suspected device novopen echo has been returned to novo nordisk for evaluation.Upon investigation, some foreign dry matter was observed on the mechanical parts of the pen.This had caused increased friction of the pen during dosage.The observed problem was due to incorrect handling of the pen.The fault is considered to be obvious to the user.It is not possible to use the pen as intended as it blocks.A spare pen should be used.If a spare pen is not available, the patient will receive no dose and result in hyperglycaemia.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.# reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.H3 continued: evaluation summary.Name: novopen echo red, batch number: fvg8415-1.A visual examination of the returned and functional testing were performed.Foreign dry matter observed on internal or external pen parts e.G., dust, dirt, or dried stains after a liquid.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 electronic register was checked.The readout revealed indications of use of the pen with no flow in the delivery system.The function of the piston rod was found to be normal.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.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 two lines (- -) or 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
• 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: 12370234
• MDR Text Key: 268231085
• Report Number: 9681821-2021-00045
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: FVG8415-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 00000-7/3/17-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male