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

Model Number N/A

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Patient's blood sugar levels went down to 1.3 mmol/l and went unconscious [hypoglycaemic unconsciousness].Novopen 4 delivering too much insulin [device malfunction].Novopen 4 delivering too much insulin [incorrect dose administered by device].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "patient's blood sugar levels went down to 1.3 mmol/l and went unconscious" with an unspecified onset date, "novopen 4 delivering too much insulin" with an unspecified onset date, "novopen 4 delivering too much insulin" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy", mixtard 30/70 penfill (insulin human) from unknown start date due to "drug use for unknown indication" (dose and frequency is unknown), and novofine (needle) from unknown start date due to "device therapy".Patient's height, weight and body mass index not reported.Medical history was not provided.Concomitant products included - novofine (needle).Treatment medication included glucose (glucose).The patient felt the device was delivering too much insulin.It was reported that on an unknown date the patient's blood sugar levels went down to 1.3 mmol/l and went unconscious.The patient was admitted to hospital and was given an iv infusion of glucose.They stabilised the patient and he went home the next day.On an unknown date, the patient had recovered.Action taken to novopen 4 was not reported.Action taken to mixtard 30/70 penfill was not reported.The outcome for the event "patient's blood sugar levels went down to 1.3 mmol/l and went unconscious" was recovered.The outcome for the event "novopen 4 delivering too much insulin" was not reported.The outcome for the event "novopen 4 delivering too much insulin" was not reported.No further information available.Company comment: the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30/70.

Event Description

Case description: investigation results: name: novopen 4, batch number: evg5404-1.The device was returned with the cartridge from this case mounted.Visual and functional examinations 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.On receipt there was a gap between piston rod of the device and the rubber piston in the cartridge and the piston rod was fully retracted.If the user attempted to make an air shot or to dose prior to this no insulin would have been dispensed.The user either retracted the piston rod correctly during change of the cartridge, but mounted a partly used cartridge afterwards without ensuring contact between the piston rod and the rubber piston by following the air shot procedure, the user left the needle on the pen between injections, or the user retracted the piston rod between injections.Visual and functional examinations were performed.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Name: mixtard 30/70 penfill , batch number: gr7b140.A visual examination of the returned product was performed.It is not possible to test the cartridge for inaccuracy.A small amount of air was present in the cartridge.However, this is quite normal and within product specification.Parameters identity, assay and degradation were examined.The complaint sample had been taken into use and the assay result is too low and out of in-use specification.This is probably due to an inhomogeneous extraction of the insulin from the cartridge.All other results are within the shelf life specification.The product concentration in the used sample was found to be too low.This is due to inhomogeneous extraction.The observed problem is due to incorrect handling of the product.Name: novofine, batch number: unknown.Microscopic examination performed.1 used needle found.The needles tested for flow with measure threads.The flow met specification.A visual examination of the back needle of the returned product was performed.The back needle met specification.Needle points on patient needles examined visually for defects.1 used needle with a hook on front needle.Needles tested for silicone on patient needle.The silicon met specification.The used needle had a damaged needle point.The user may experience increased pain or difficulties during penetration.The observed fault is a result of accidental damage during use.No further information available.Since last submission, the following has been updated in the case: investigation results updated.Manufacturer's comment updated.Narrative updated accordingly.Approval # for mixtard 30/70 penfill added.Device codes updated.Manufacturer's comment/company comment : 26-oct-2018: since no faults were found on the returned device novopen 4 and on receipt there was a gap between piston rod of the device and the rubber piston in the cartridge and the piston rod was fully retracted with 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 and thus not possible to find similar incidents to the one reported in (b)(4).Also,the complaint sample mixtard 30/70 had been taken into use and the assay result was too low and out of in-use specification.This was probably due to an inhomogeneous extraction of the insulin from the cartridge.All other results were within the shelf life specification.The product concentration in the used sample was found to be too low.This is due to inhomogeneous extraction.When using insulin in suspension it is very important to re-suspend the product properly in order to obtain the same potency during the entire period of use.It is also important that the insulin dose is injected immediately after re-suspending the content gently until the suspension is homogeneous.Inadequate re-suspension can result in the injection of insulin that a too high or too low concentration.The observed problem was due to incorrect handling of the product/user error.The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30/70.Evaluation summary: name: novopen 4, batch number: evg5404-1.The device was returned with the cartridge from this case mounted.Visual and functional examinations 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.On receipt there was a gap between piston rod of the device and the rubber piston in the cartridge and the piston rod was fully retracted.If the user attempted to make an air shot or to dose prior to this no insulin would have been dispensed.The user either retracted the piston rod correctly during change of the cartridge, but mounted a partly used cartridge afterwards without ensuring contact between the piston rod and the rubber piston by following the air shot procedure, the user left the needle on the pen between injections, or the user retracted the piston rod between injections.Visual and functional examinations were performed.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7927530
• MDR Text Key: 122379394
• Report Number: 9681821-2018-00059
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: EVG5404-1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NOVOFINE (NEEDLE) N/A; NOVOFINE (NEEDLE) N/A
• Patient Outcome(s): Hospitalization
• Patient Age: 91 YR