MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339); Device Fell (4014)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

Spent in a&e where blood sugars were in mid 20s [blood glucose abnormal].Ketones were high [blood ketone body increased].Pen programmed to insert 52 units but it showed 14 units to be taken [incorrect dose administered by device].Cartridge holder broke [device breakage].Pen went out of their hand onto the carpet [device dislocation].Used expired novopen 5 [expired device used].Case description: this serious spontaneous case from the (b)(6) was reported by a consumer as "spent in a&e where blood sugars were in mid 20s(blood glucose abnormal)" beginning on (b)(6) 2020, "ketones were high(blood ketone body increased)".Beginning on (b)(6) 2020, "pen programmed to insert 52 units but it showed 14 units to be taken(incorrect dose administered by device)" beginning on (b)(6) 2020, "cartridge holder broke (device breakage)" with an unspecified onset date, "pen went out of their hand onto the carpet (device slipped)" with an unspecified onset date, "used expired novopen 5(expired device used)" with an unspecified onset date, and concerned a (b)(6) patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", , novomix 30 (insulin aspart) from unknown start date for "product used for unknown indication" (dose and freqency unknown).The patient's height, weight and body mass index were reported.Medical history was not provided.On (b)(6) 2020 17.30, when patient programmed pen to insert 52 units of novomix 30 and touched the dose button, it went straight in.The plunger went straight in showing patient had taken 37 units.Patient did not feel the insulin go in as it normally feel it do.When looked at the number on device, it showed 14 units to be taken.Patient took them and at 21.30 patient's sugars were in the mid 20's (units not reported).It was reported that patient had to spend wednesday night ((b)(6) 2020 at 21:45) and thursday morning ((b)(6) 2020 at 01:45) in a&e (accident and emergency) and said "i thought i was dying".A&e confirmed that patient had not taken full 52 units and had ketones which were high (values not reported).After 4 hours in accident and emergency they allowed patient to go home.It was reported that patient's pen went out of their hand onto the carpet a few days earlier and the cartridge holder is also broke.Patient stated they were put on the novopen 5 as the novopen 3 or 4 they had they couldn't see the writing on it.Batch numbers: novopen 5: fvg7617.Novomix 30: asku.Action taken to novopen 5 was not reported.Action taken to novomix 30 was not reported.The outcome for the event "spent in a&e where blood sugars were in mid 20s(blood glucose abnormal)" was not reported.The outcome for the event "ketones were high(blood ketone body increased)" was not reported.The outcome for the event "pen programmed to insert 52 units but it showed 14 units to be taken(incorrect dose administered by device)" was not reported.The outcome for the event "cartridge holder broke(device breakage)" was not reported.The outcome for the event "pen went out of their hand onto the carpet(device slipped)" was not reported.The outcome for the event "used expired novopen 5(expired device used)" was not reported.The returned device will be investigated to evaluate it works according to the set specifications and intended use.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: e2b report duplicate.Reference id#: (b)(4).Reference notes: mhra reference number.

Event Description

Case description: investigation results.Name: novopen 5.Batch number: fvg7617.A visual examination of the returned product was performed.The snap connection on the cartridge holder is damaged.As a consequence, the cartridge holder may be difficult or impossible to mount on the pen body and the dose accuracy may be affected.Due to the damage to the cartridge holder, the pen could not be tested for function with a needle and a cartridge attached to it.The fault was caused by an error in novo nordisk a/s.In the readout of the electronic pen memory it was revealed that the electronic display has shown two lines; after the dose button was fully depressed.This was because the user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes before the entire dose was fully delivered.The two lines in the display was a normal function of the pen to warn the user of not recommended user behaviour.Furthermore, this can happen when the previous selected dose(s) were not fully injected, before a new dose was selected and fully injected.The observed problem was caused by unintended use of the device.The fault was caused by an error in novo nordisk.Name: novomix 30.Batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, the following information has been updated in the case, -investigation results updated.-device addendum tab updated.-narrative updated accordingly.Final manufacturer comment: (b)(6) 2020:the patient stated that the suspected pen was dropped on the floor prior to experiencing a hyperglycaemic event and visited the emergency room for treatment.The suspected pen was returned to novo nordisk for investigation and the results of the investigation showed that the pen had a damaged cartridge holder related to the fsca (b)(4)conducted q2 2017.The malfunction were related to a novo nordisk design error and it cannot be excluded that it could have contributed to the experienced hyperglycaemic event.H3 continued: evaluation summary investigation results.Name: novopen 5.Batch number: fvg7617.A visual examination of the returned product was performed.The snap connection on the cartridge holder is damaged.As a consequence, the cartridge holder may be difficult or impossible to mount on the pen body and the dose accuracy may be affected.Due to the damage to the cartridge holder, the pen could not be tested for function with a needle and a cartridge attached to it.The fault was caused by an error in novo nordisk a/s.In the readout of the electronic pen memory it was revealed that the electronic display has shown two lines; after the dose button was fully depressed.This was because the user split the selected dose into two or more smaller doses which were delivered over a period of more than 15 minutes before the entire dose was fully delivered.The two lines in the display was a normal function of the pen to warn the user of not recommended user behaviour.Furthermore, this can happen when the previous selected dose(s) were not fully injected, before a new dose was selected and fully injected.The observed problem was caused by unintended use of the device.The fault was caused by an error in novo nordisk. .

Event Description

Case description: since last submission, the following information has been updated in the case: annex e, g code updated.Correction of imdrf code annex c as per follow up.Narrative updated accordingly.

• Brand Name: NOVOPEN 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• MDR Report Key: 10615325
• MDR Text Key: 252828181
• Report Number: 9681821-2020-00041
• 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
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2018
• Device Model Number: N/A
• Device Lot Number: FVG7617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR