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

Model Number N/A

Device Problems Crack (1135); Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Hyperglycaemia [hyperglycaemia].Small crack in the cartridge holder that made the piston not work properly [device breakage].The piston not work properly, thus causing the possible loss of doses.[drug delivery system malfunction].High levels of ketone bodies [blood ketone body increased].This serious spontaneous case from (b)(6) was reported by a pharmacist as "hyperglycaemia(hyperglycaemia)" with an unspecified onset date, "small crack in the cartridge holder that made the piston not work properly(device breakage)" with an unspecified onset date, "the piston not work properly, thus causing the possible loss of doses.(drug delivery system malfunction)" with an unspecified onset date, "high levels of ketone bodies(blood ketone body increased)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index not reported.Medical history was not provided.On an unknown date, the patient started treatment with novopen echo.On an unknown date, the patient experienced hyperglycaemia , exceeding 300 and even 400 mg/dl (treatment details not specified) because the patient noticed a small crack in the cartridge holder that made the piston not work properly, thus causing the possible loss of doses after the pen was disassembled on (b)(6) 2021 the patient was hospitalized due to several days of hyperglycaemia.On (b)(6) 2021, patient discharged from the hospital).Patient also had high levels of ketone bodies (dates not specified).Batch number of novopen echo was dv40072 (non-valid) action taken to novopen echo was not reported.The outcome for the event "hyperglycaemia(hyperglycaemia)" was not reported.The outcome for the event "small crack in the cartridge holder that made the piston not work properly(device breakage)" was not reported.The outcome for the event "the piston not work properly, thus causing the possible loss of doses.(drug delivery system malfunction)" was not reported.The outcome for the event "high levels of ketone bodies(blood ketone body increased)" was not reported.Preliminary manufacturer's comment: 26-jul-2021: the suspected device novopen echo has not been returned to novo nordisk for investigation.No conclusion is reached.

Event Description

Case description: this serious spontaneous case from spain was reported by a pharmacist as "hyperglycaemia(hyperglycaemia)" beginning on (b)(6) 2021, "small crack in the cartridge holder that made the piston not work properly(device breakage)" with an unspecified onset date, "the piston not work properly, thus causing the possible loss of doses.(drug delivery system malfunction)" with an unspecified onset date, "high levels of ketone bodies(blood ketone body increased)" with an unspecified onset date, and concerned a 15 years old male patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", on (b)(6) 2021, the patient experienced hyperglycaemia and was hospitalized due to several days.The blood glucose levels were exceeding 300 and even 400 mg/dl (treatment details not specified) because the patient noticed a small crack in the cartridge holder that made the piston not work properly, thus causing the possible loss of doses after the pen was disassembled the force needed to inject was normal.The patient use the dialing clicks to estimate the dose of the product and attach the needle to the pen in a 180 degree angle (straight on).A new pen was received by the patient.On (b)(6) 2021 the outcome for the event "hyperglycaemia(hyperglycaemia)" was recovered.The outcome for the event "small crack in the cartridge holder that made the piston not work properly(device breakage)" was not reported.The outcome for the event "the piston not work properly, thus causing the possible loss of doses.(drug delivery system malfunction)" was not reported.The outcome for the event "high levels of ketone bodies(blood ketone body increased)" was recovered.Investigation result: novopen echo - batch dv40072.A visual examination of the returned product was performed.The cartridge holder was damaged in its connection to the mechanical part of the pen.It was not possible to attach the cartridge holder correctly and the device could not function with a needle and a cartridge attached.This would also affect the plunger.The dose accuracy might be affected.The fault was caused by accidental damage during use of the device.The electronic register was checked.The results showed that the pen had been in use for 5 years.The pen had reached its end of life.Visual examination and functional testing were performed.The memory display showed "end".Mechanical functions which could be tested without the cartridge holder attached to the pen were found to be normal.Since last submission 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-aug-2021: the suspected device novopen echo has been returned to novo nordisk for investigation.It was found that cartridge holder was damaged due to accidental damage during the use of the device.It is not possible to attach the cartridge holder correctly and the device cannot function with a needle and a cartridge attached.The dose accuracy may be affected.If the user does not detect the fault on the cartridge holder there is a risk that the patient will only receive a partial or no dose at all and could experience hyperglycemic related events.It thus cannot be excluded that the damaged cartridge holder could have contributed to the experienced hyperglycaemia.H3 continued: evaluation summary: novopen echo - batch dv40072.A visual examination of the returned product was performed.The cartridge holder was damaged in its connection to the mechanical part of the pen.It was not possible to attach the cartridge holder correctly and the device could not function with a needle and a cartridge attached.This would also affect the plunger.The dose accuracy might be affected.The fault was caused by accidental damage during use of the device.The electronic register was checked.The results showed that the pen had been in use for 5 years.The pen had reached its end of life.Visual examination and functional testing were performed.The memory display showed "end".Mechanical functions which could be tested without the cartridge holder attached to the pen were found to be normal.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• MDR Report Key: 12273174
• MDR Text Key: 264945666
• Report Number: 9681821-2021-00042
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Lot Number: DV40072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Date Manufacturer Received: 08/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 15 YR