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

Model Number N/A

Device Problems Device Difficult to Setup or Prepare (1487); Inaccurate Delivery (2339)

Patient Problems Hyperglycemia (1905); Electrolyte Imbalance (2196)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Extremely high blood glucose values [blood glucose increased].More force was needed to inject [device malfunction].Novopen echo delivers insulin unreliably [incorrect dose administered by device].Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "extremely high blood glucose values (blood glucose increased)" with an unspecified onset date, "more force was needed to inject(device component malfunction)" with an unspecified onset date, "novopen echo delivers insulin unreliably(incorrect dose administered by device)" with an unspecified onset date, and concerned a (b)(6)-year-old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus" and novorapid penfill (insulin aspart) from unknown start date and ongoing for "type 1 diabetes mellitus".Patient's height, weight and body mass index were not reported.Current condition: type 1 diabetes mellitus (for approximately 2 years).No concomitant diseases.Concomitant products included - levemir penfill(insulin detemir) solution for injection,.0024 mol/l.On an unknown date, the patient experienced extremely high blood glucose values during use of novopen echo.Pen delivered insulin unreliably and the blood glucose value were up to 340 mg/dl.It was reported that more force was needed to inject.On (b)(6) 2020, the patient was in hospital for outpatient treatment, not inpatient.With the help of a replacement pen patient was able to get her blood glucose values under control again.It was reported that the patient was the user of device and has been trained by a health care professional to use.It was reported that patient store the insulin in use at room temperature 20 - 25 °c.Batch number novopen echo: gvge191 novorapid penfill: jr70b40.Action taken to novopen echo was not reported.Action taken to novorapid penfill was not reported.The outcome for the event "extremely high blood glucose values(blood glucose increased)" was recovered.The outcome for the event "more force was needed to inject(device component malfunction)" was not reported.The outcome for the event "novopen echo delivers insulin unreliably(incorrect dose administered by device)" was not reported.Manufacturer's preliminary comment: the suspected device novopen echo has been returned to novo nordisk for investigation.The evaluation of the device is ongoing.Final conclusion on the reported events will be reached after the complete investigation.The young patient ((b)(6) years old) with medical condition of type 1 diabetes mellitus is at increased risk of developing hyperglycaemia.

Event Description

Case description: investigation results: product name: novopen echo®, batch: gvge191.The device was returned with the cartridge from this case mounted.Upon receipt of device the mounted penfill® was under pressure, indicating an attempt to deliver insulin without any flow in the insulin delivery system (device / penfill® / 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 electronic register was checked.The readout revealed several indications of use of the pen with no flow in the delivery system.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.The fault is caused by incorrect handling during use of the device.Product name: novorapid® penfill®, batch: jr70b40.Visual examination was performed.A complaint sample has been analysed chemically.All results were within specification.The returned cartridge was tested for friction.The result was within specification.It is not possible to test the cartridge for inaccuracy.During examination of the product no irregularities were detected.The product was found to be normal.Since last submission, the following information has been updated in the case: investigation results updated, manufacture's comment updated, narrative updated accordingly.Manufacturer's final comment: 24-jul-2020: the suspected device (novopen echo) has been returned to novo nordisk for evaluation.Upon investigation, it revealed use of clogged needle.The fault is caused by incorrect handling during use of the device.Small pieces of glass were observed on the joints round the piston rod.Damaged pen parts were observed as a result of the use of a cracked or broken cartridge in the device and/or glass fragment(s) observed in the pen mechanism.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.H3 continued: evaluation summary: investigation results: product name: novopen echo®, batch: gvge191.The device was returned with the cartridge from this case mounted.Upon receipt of device the mounted penfill® was under pressure, indicating an attempt to deliver insulin without any flow in the insulin delivery system (device / penfill® / 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 electronic register was checked.The readout revealed several indications of use of the pen with no flow in the delivery system.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.The fault is caused by incorrect handling during use of the device.

Event Description

Case description: investigation results.Product name: novopen echo®.Batch: gvge191.The device was returned with the cartridge from this case mounted.Upon receipt of device the mounted penfill® was under pressure, indicating an attempt to deliver insulin without any flow in the insulin delivery system (device/penfill®/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 piston rod was difficult to retract.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic register was checked.The readout revealed several indications of use of the pen with no flow in the delivery system.Microscopic examination performed.Small pieces of glass were observed on the joints round the piston rod.Damaged pen parts were observed as a result of the use of a cracked or broken cartridge in the device and/or glass fragment(s) observed in the pen mechanism.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.The fault is caused by incorrect handling during use of the device.Product name: novorapid® penfill®.Batch: jr70b40.Visual examination was performed.A complaint sample has been analysed chemically.All results were within specification.The returned cartridge was tested for friction.The result was within specification.No abnormalities relating to the observed problem were found.Nonconformity-related documentation was examined.No irregularities recorded and therefore no further action.The batch documentation has been reviewed and found to be normal.It is not possible to test the cartridge for inaccuracy.During examination of the product no irregularities were detected.The product was found to be normal.Since last submission, the following information has been updated in the case: -annex a, c, e, f, and g updated.-investigation results updated.-manufactuer's comment updated.-narrative updated accordingly.Manufacturer's final comment: (b)(6) 2020: the suspected device (novopen echo) has been returned to novo nordisk for evaluation.Upon investigation, it revealed use of clogged needle.The fault is caused by incorrect handling during use of the device.Small pieces of glass were observed on the joints round the piston rod.Damaged pen parts were observed as a result of the use of a cracked or broken cartridge in the device and/or glass fragment(s) observed in the pen mechanism.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.H3 continued: evaluation summary: investigation results.Product name: novopen echo®.Batch: gvge191.The device was returned with the cartridge from this case mounted.Upon receipt of device the mounted penfill® was under pressure, indicating an attempt to deliver insulin without any flow in the insulin delivery system (device/penfill®/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 piston rod was difficult to retract.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The electronic register was checked.The readout revealed several indications of use of the pen with no flow in the delivery system.Microscopic examination performed.Small pieces of glass were observed on the joints round the piston rod.Damaged pen parts were observed as a result of the use of a cracked or broken cartridge in the device and/or glass fragment(s) observed in the pen mechanism.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.The memory data in the device has revealed that the memory display has shown two lines (- -) after an attempted injection during use.The observed problem is caused by the use of a clogged needle on the pen.The fault is caused by incorrect handling during 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
• MDR Report Key: 10128488
• MDR Text Key: 200856729
• Report Number: 9681821-2020-00027
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2019
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: GVGE191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVEMIR PENFILL (INSULIN DETEMIR).
• Patient Outcome(s): Other
• Patient Age: 13 YR