MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Defective Component (2292); Defective Device (2588); Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Blood sugar and it was 29 [hyperglycaemia].Black piece in the pen is not quite stable [device issue].Pen is not giving the right dose [incorrect dose administered by device].Faulty pen [device defective].This serious spontaneous case from (b)(6) was reported by a consumer as "blood sugar and it was 29(hyperglycemia)" with an unspecified onset date, "black piece in the pen is not quite stable(device component issue)" with an unspecified onset date, "pen is not giving the right dose(incorrect dose administered by device)" with an unspecified onset date, "faulty pen(device defective)" with an unspecified onset date, and concerned a male patient age (not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", novorapid (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - 10 units, unknown) from unknown start date for "drug use for unknown indication", patient height, weight and body mass index not reported.Medical history was not provided.On an unknown date patient experienced hyperglycaemia and patient was hospitalized.The black piece in the pen was not quite stable and it has clicked a couple of times and thought maybe the pen was not giving the right dose.It may be a faulty pen as something was wrong with the black piece as sometimes insulin doesn't come out and he doesn't inject insulin therefore could be a problem pen that could only be giving 2 units.Patient gave himself 10 units of novorapid.The blood sugar was tested which was high and his blood sugar was 22-25 (units not reported) and it kept going up and after one hour was 29(units not reported) when it should be coming down.It was now 11.5(units not reported) at 10 past 2 which was a long time for it to come down.Batch number for novopen 4 has been requested.Batch number for novorapid has been requested.Action taken to novorapid was not reported.The outcome for the event "blood sugar and it was 29(hyperglycemia)" was unknown.The outcome for the event "black piece in the pen is not quite stable(device component issue)" was unknown.The outcome for the event "pen is not giving the right dose(incorrect dose administered by device)" was not reported.The outcome for the event "faulty pen(device defective)" was not reported.Preliminary manufacturer's comment: on 18-aug-2021: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "blood sugar and it was 29(hyperglycemia)" with an unspecified onset date, "black piece in the pen is not quite stable(device component issue)" with an unspecified onset date, "pen is not giving the right dose(incorrect dose administered by device)" with an unspecified onset date, "faulty pen(device defective)" with an unspecified onset date, and concerned a male patient (born in 1947) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", novorapid (insulin aspart) from unknown start date for "drug use for unknown indication".Concomitant medication : lantus.Batch number for novopen 4: xug0353.Batch number for novorapid has been requested.Action taken to novopen 4 was not reported: references included: reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same patient.Since last submission, the case has been updated with the following: -mhra report number was updated.-year of birth updated in narrative.-concomitant medication lantus added.-novopen returned to manufacturer updated in product tab.-batch number of novopen updated.-device narrative updated.-narrative generated accordingly.Preliminary manufacturer's comment: 03-sep-2021: the suspected device (novopen 4) has been returned to novo nordisk for evaluation.Investigation is ongoing.

Event Description

Case description: investigation results: suspect product: novopen 4, batch number: xug0353.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.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.The observed fault was a result of accidental damage during use of the device.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 black disk/piston rod washer was found to be normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The product was found to be normal.During examination of the product, no irregularities related to the complaint were detected.Investigation results: name: novorapid, 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 has been updated with the following: -investigation results updated.-b,c,d,g codes added.-narrative updated accordingly.Final manufacturer's comment: 27-sep-2021: the suspected device (novopen 4) has been returned to novo nordisk for evaluation.Upon investigation, device was found to work as specified.No device problem found.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.Since no faults were found on the returned device novopen 4 and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event of hyperglycaemia.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of novorapid.H3 continued: evaluation summary suspect product: novopen 4, batch number: xug0353.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.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.The observed fault was a result of accidental damage during use of the device.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 black disk/piston rod washer was found to be normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The product was found to be normal.During examination of the product, no irregularities related to the complaint were detected.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 12377587
• MDR Text Key: 268479213
• Report Number: 9681821-2021-00046
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: XUG0353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 08/31/2021; 09/23/2021
• Supplement Dates FDA Received: 09/15/2021; 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LANTUS (INSULIN GLARGINE)
• Patient Outcome(s): Hospitalization