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

Model Number N/A

Device Problems Unintended Collision (1429); Device Displays Incorrect Message (2591)

Patient Problem Diabetic Ketoacidosis (2364)

Event Date 02/01/2020

Event Type  Injury  

Event Description

(related symptoms if any separated by commas), blood glucose level was then 23.3 mmol/l also got ketones in the blood [diabetic ketoacidosis], the memory function stopped working, it only showed lines [device information output issue], crack in the penfill (their guess is that the plunger has broken the penfill) [product physical issue].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "blood glucose level was then 23.3 mmol/l also got ketones in the blood(diabetic ketoacidosis)" beginning on (b)(6) 2020, "the memory function stopped working, it only showed lines(device information output issue)" beginning on (b)(6) 2020, "crack in the penfill (their guess is that the plunger has broken the penfill) (cracked product)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo (insulin delivery device) from (b)(6) 2019 for "type 1 diabetes mellitus", fiasp penfill (insulin aspart) from (b)(6) 2019 for "type 1 diabetes mellitus" (dose and frequency unknown).Patient's height: 95 cm, patient's weight: (b)(6), patient's bmi: 14.40443210.Current condition: type 1 diabetes mellitus since (b)(6) 2019.On (b)(6) 2020, pen's memory function stopped working, it only showed lines.When they did the test the pen worked but not when the dose was given.The patient got high blood glucose and they did not get it down, they had to go to the emergency and blood glucose level was then 23.3 mmol/l and he also got ketones in the blood.When they change the penfill at the hospital, they saw a crack in the penfill.Their guess is that the plunger has broken the penfill, it is in the mouth itself the penfill is broken.They do not know that the pen has been dropped at some point, but it is also used at the preschool.The nurse was informed of the incident.It was reported that the patient could leave the hospital immediately after the blood glucose had decreased.The patient was feeling well at the time of reporting.Have no other medication.Normal blood glucose levels are 4-8 mmol/l.Batch number of novopen echo was hvgm561-5.Batch number of fiasp penfill not available since the penfills has been thrown away.Action taken to novopen echo was not reported.Action taken to fiasp penfill was not reported.The outcome for the event "blood glucose level was then 23.3 mmol/l also got ketones in the blood(diabetic ketoacidosis)" was recovered.The outcome for the event "the memory function stopped working, it only showed lines(device information output issue)" was recovered.The outcome for the event "crack in the penfill (their guess is that the plunger has broken the penfill) (cracked product)" was not reported.

Event Description

Case description: batch numbers: novopen echo: (b)(4).Fiasp penfill: (b)(4).Investigation result: name: novopen echo - batch hvgm561-5.The device was returned with the cartridge from this case mounted.The electronic register was checked.Several mitigation codes indicating foreign matter on electronic parts was observed.The memory display showed two lines.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.The pen did not crack the cartridge penfill when mounted to the pen body.During testing it was possible to deliver preparation from the cartridge.The piston rod was difficult to retract.Microscopic examination performed.Small pieces of glass and scratches was observed on the piston rod and surrounding joints.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The device was disassembled to examine internal parts.Microscopic examination performed.Foreign matter was observed on electronic parts.Confirmed 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.Confirmed the memory display showed: (two lines) after injection and it is not possible to see the last injected dosage in the memory display.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.Name: fiasp penfill - batch js69l69.A complaint sample has been analysed chemically.A visual examination of the returned product was performed.The returned product was examined visually and was cracked.In addition, leakage was observed.The pattern of the cracks indicates that the glass has been subject to an excessive stress.This type of high-energy stress breakage is not consistent with processes at novo nordisk.The breakage was due to incorrect or rough handling of the product after it has left novo nordisk.All the results were as expected and within acceptable limits.During examination of the product no irregularities were detected.The product was found to be normal.In order to protect the safety of patient it will, in rare cases, be required to disassemble the device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the device).The disassembled device will be stored with the same retention period as other complaint samples.Since last submission the case has been updated with the following: "the case downgraded to final non-reportable incident." references included: reference type: mw 3500a mfr.Rpt.#, reference id#: 9681821-2020-00014, reference notes: medwatch 3500a mfr.Report number, reference type: e2b linked report, reference id#: (b)(4).Reference notes: same reporter.Manufacturer comment: on 28-apr-2020: the suspected device (novopen echo) and fiasp penfill cartridge were returned to novo nordisk for evaluation.Investigation of the device showed foreign matter on electronic parts, which affects the memory function of the pen, and it could not influence on the mechanical functioning of the pen.Pen was found to be damaged as a result of the use of a cracked or broken cartridge and/or glass fragment(s) observed in the pen mechanism.Fiasp cartridge testing revealed cracks due to incorrect or rough handling of the product.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.Due to the cracks, the dosage can be inaccurate and closure integrity might be compromised; resulting in diabetic ketoacidosis.H3 continued: evaluation summary: name: novopen echo - batch hvgm561-5.The device was returned with the cartridge from this case mounted.The electronic register was checked.Several mitigation codes indicating foreign matter on electronic parts was observed.The memory display showed two lines.Visual examination and functional testing were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.The pen did not crack the cartridge penfill when mounted to the pen body.During testing it was possible to deliver preparation from the cartridge.The piston rod was difficult to retract.Microscopic examination performed.Small pieces of glass and scratches was observed on the piston rod and surrounding joints.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The device was disassembled to examine internal parts.Microscopic examination performed.Foreign matter was observed on electronic parts.Confirmed 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.Confirmed the memory display showed: (two lines) after injection and it is not possible to see the last injected dosage in the memory display.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.

Event Description

Case description: investigation result: name: novopen echo - batch hvgm561-5, the product was not returned for investigation.Name: fiasp penfill - 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: laboratory data updated.Investigation results were updated.Manufacturer's comment updated.Narrative updated accordingly.Manufacturer comment: 13-mar-2020: as the device (novopen echo) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event.H3 continued: evaluation summary: name: novopen echo - batch hvgm561-5.The product was not returned for investigation.

Event Description

Case description: patient's bmi: 14.404.On 30-mar-2021, an amendment was performed.Since last submission the following information has been amended: the case was initially marked as non-reportable and is now corrected as 'reportable'.All the required fields for final reportable incidents filled.Since last submission the following has been updated: patient bmi.Annex a and f changed.Amendment was performed.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 9794957
• MDR Text Key: 192420801
• Report Number: 9681821-2020-00014
• 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: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: HVGM561-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 2 YR
• Patient Weight: 13