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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Component (2292); Failure to Deliver (2338)

Patient Problem Hyperglycemia (1905)

Event Date 11/01/2020

Event Type  Injury  

Event Description

Hyperglycemia [hyperglycaemia].Novopen4 the dose button could not pressed [device malfunction].Novopen 4 did not work normally [device defective].Novopen4 did not inject the insulin [device failure].Patient used dialling clicks to estimate the dose of the insulin [wrong technique in product usage process].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycemia(hyperglycemia)" beginning on (b)(6) 2020, "novopen4 the dose button could not pressed(device component malfunction)" beginning on (b)(6) 2020, "novopen 4 did not work normally(device defective)" beginning on (b)(6) 2020, "novopen4 did not inject the insulin(device failure)" beginning on (b)(6) 2020, "patient used dialling clicks to estimate the dose of the insulin(wrong technique in product usage process)" 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 "diabetes mellitus" and actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency & route used - unk (since 8 years), unknown) (therapy dates - ongoing) from unknown start date and ongoing for "diabetes mellitus", the patient height, weight and body mass index were not reported.Current condition: diabetes mellitus (type and duration not reported).The reporter complained that on an unknown date of (b)(6) 2020 (reported as a month ago), the patient suffered from hyperglycemia as his blood level glucose up to 630 mg/dl when he used actrapid as the novopen 4 did not work normally.Patient complained that his novopen 4 did not inject the insulin as the dose button could not pressed although the dose button pressed normally when he removed the penfill and the needle.Patient was offered pen training and during the training the piston rod did not move for several times when we check the mechanical part and adjusted the dose counter on 60 iu and pressed it the piston rod did not move.Patient has been using actrapid from 7 years and he stopped taking it one week before the event as the novopen 4 was not working normally.It was also reported that the patient used dialling clicks to estimate the dose of the insulin.In general patient reused the needles.Needle(unspecified) was attached to the pen in between injections, the force needed to inject was normal, the patient haven't been recently changed your diet or exercise level, the patient haven't changed from another novopen to the current novopen.Batch numbers: actrapid penfill: asku, novopen 4: fvg7971.Action taken to actrapid penfill was reported as no change.Action taken to novopen 4 was product discontinued due to adverse event (ae).References included: reference type: e2b company number.Reference id#: (b)(4).Preliminary manufacturer's comment: 21-dec-2020: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.No conclusion has been reached.Product handling error such as needle re-use, leaving the needle attached to device between injections, using dialing clicks to estimate the insulin dosage are significant risk factors which could have lead to device malfunction and cause variation in drug delivered.Additionally stopping the administration of insulin for one week could have lead to hyperglycaemia.

Event Description

Case description: investigation results.Name: novopen® 4 batch fvg7971.The product was not returned for examination.No investigation was possible, because sample was not available.Name: actrapid®.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 updates: -investigation results updated.-annex b,c,d and g updated.-manufacturer's comment updated.-narrative updated accordingly.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2020-00066.Reference notes: medwatch 3500a mfr.Report number.Final manufacturer's comment: 01-feb-2021: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.With available limited information, it is not possible to identify a clear root-cause of the experienced adverse event.Product handling error such as needle re-use, leaving the needle attached to device between injections, using dialing clicks to estimate the insulin dosage are significant risk factors which could have led to device malfunction and cause variation in drug delivered.Additionally stopping the administration of insulin for one week could have led to hyperglycaemia.Company comment: the reported events are listed.The suspected product (actrapid penfill) has not been returned to novo nordisk for evaluation.No investigation was possible, because neither sample nor batch number was available.With the available limited information, hyperglycaemia could be attributed to product handling error.This single case report is not considered to change the current knowledge of the safety profile of actrapid penfill.H3 continued: evaluation summary.Investigation results: name: novopen® 4.Batch fvg7971.The product was not returned for examination.No investigation was possible, because sample was not available.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11066951
• MDR Text Key: 229816030
• Report Number: 9681821-2020-00066
• 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
• Report Date: 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: FVG7971
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other