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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

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

Event Date 12/01/2017

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Diabetic ketoacidosis [diabetic ketoacidosis].Novopen pen echo is not delivering [device failure].High blood sugars [blood glucose increased].Ketones in urine [urine ketone body present].Case description: this serious spontaneous case from the united states was reported by a medical doctor as "diabetic ketoacidosis" beginning on (b)(6) 2017, "novopen pen echo is not delivering" beginning on (b)(6) 2017, "high blood sugars" beginning on (b)(6) 2018, "ketones in urine" beginning on (b)(6) 2018, and concerned a (b)(6) years old female patient who was treated with novolog penfill (insulin aspart) (dose, frequency and route used of 1 units for every 9 grams of carbs, unknown) from unknown start date and ongoing due to "type 1 diabetes mellitus" and novopen echo (insulin delivery device) from unknown start date and ongoing due to "type 1 diabetes mellitus".Patient's weight: (b)(6) kg.Weight has been rounded to a whole number due to e-submitter limitation with decimal patient's height reported as height: (b)(6) ft.Medical history included type 1 diabetes mellitus (duration: not reported), cornelia de lang syndrome.Concomitant products included - levemir (insulin detemir) solution for injection,.0024 mol/l.Treatment included - insulin (insulin).It was reported that the patient started to use novolog penfill 21 years ago.The patient had been using the same pen for the past couple of years.The reporter noted that the electronic display stopped working on the novopen echo a few years ago, but the patient continued to use the pen.On an unknown date, the patient's glycosylated haemoglobin (hba1c) was 7.5% and 7.2 %.It was reported that, novopen echo was not working since (b)(6) 2017 and the patient had dka (diabetic ketoacidosis).The patient used 3-4 cartridges of different batches and boxes, when the novopen echo was not delivering.In (b)(6) 2017, the patient's blood glucose was reported as over 500 mg/dl and bicarbonates was reported as 7 (units: not reported).The patient was hospitalized in an intensive care unit due to dka (diabetic ketoacidosis) on (b)(6) 2017.During the hospitalization, the patient's hba1c for diabetic ketoacidosis was 8.5%, ketone urine was 80 (unit: not reported) and beta-hydroxybutyrate was greater than 9 (unit: not reported).The patient was treated with insulin drip and recovered.The patient was discharged on (b)(6) 2018.After being discharged home, the patient started experiencing elevated blood sugars again with ketones in urine on (b)(6) 2018.The blood glucose was reported as over 400 mg/dl.The patient's father realized that there was something wrong with the pen and described that when the pen was set to a horizontal position or if the tip was up the plunger would retract so the pen was not delivering the insulin.It was reported that, the patient did not dial the clicks to estimate the dose of the insulin.The operator was trained by a health care professional in the use of the novopen.The patient recently not changed diet or exercise level.The patient switched to a new novopen echo and the patient recovered.Action taken to novolog penfill was reported as no change.Action taken to novopen echo was reported as no change.On (b)(6) 2018 the outcome for the event "diabetic ketoacidosis" was recovered.The outcome for the event "novopen pen echo is not delivering" was not reported.The outcome for the event "high blood sugars" was recovered.The outcome for the event "ketones in urine" was recovered.

Event Description

Diabetic ketoacidosis [diabetic ketoacidosis] novopen pen echo is not delivering or only a portion of the selected dose [device malfunction] sometimes when the dose button was depressed, the piston rod head would not advance at all [device issue] high blood sugars [blood glucose increased] ketones in urine [urine ketone body present] case description: this serious spontaneous case from the united states was reported by a medical doctor as "diabetic ketoacidosis" beginning on (b)(6) 2017, "novopen pen echo is not delivering or only a portion of the selected dose" beginning on (b)(6) 2017, "sometimes when the dose button was depressed, the piston rod head would not advance at all" beginning on (b)(6) 2017, "high blood sugars" beginning on (b)(6) 2018, "ketones in urine" beginning on (b)(6) 2018, and concerned a (b)(6) female patient who was treated with novolog penfill (insulin aspart) from unknown start date and ongoing due to "type 1 diabetes mellitus", , novopen echo (insulin delivery device) from unknown start date and ongoing due to "type 1 diabetes mellitus", after being discharged home, the patient started experiencing elevated blood sugars again with ketones in urine on (b)(6) 2018.The blood glucose was reported as over 400 mg/dl.The patient's father realized that there was something wrong with the pen and described that when the pen was set to a horizontal position or if the tip was up the plunger would retract so the pen was not delivering the insulin.When the pen was held sideways or wit the needle end up, the piston rod head and the piston rod actually retract when the pen was dialed up to get ready to administer insulin.Thus when the dose button was depressed it actually delivered no insulin or only a portion of the selected dose.If the needle end was pointed up and lightly shaken or tapped the piston rod head and the piston rod started to fall back in to the barrel on its own.In addition if a slight amount of pressure was applied to the piston rod head, sometimes when the dose button was depressed, the piston rod head would not advance at all.It was as if the advancement mechanism inside was stripped.It was reported that, the patient did not dial the clicks to estimate the dose of the insulin.The operator was trained by a health care professional in the use of the novopen.The patient had recently not changed diet or exercise level.On (b)(6) 2018 the outcome for the event "diabetic ketoacidosis" was recovered.The outcome for the event "novopen pen echo is not delivering or only a portion of the selected dose" was not reported.The outcome for the event "sometimes when the dose button was depressed, the piston rod head would not advance at all" was not reported.The outcome for the event "high blood sugars" was recovered.The outcome for the event "ketones in urine" was recovered.Investigation result: novolog penfill 3 ml cartridges 100 units/ml (u-100) - batch unknown no investigation was possible, because neither sample nor batch number was available.Novopen echo - batch dv40073: the device was returned without the pen cap.Non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.Visual and functional examinations were performed.The memory display was blank and the electronic register could not be reached.Tiny scratches was observed on the dose indicator window.The function of the piston rod was found to be normal.The piston rod can move freely when no penfill cartridge is mounted in the pen and if it has not been fully retracted.When a penfill cartridge has been mounted properly in the pen, as described in the user manual for the product, the piston rod will no longer be able to move freely and the selected dose will be delivered accurately.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 dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.All mechanical functions are normal.The device was disassembled to examine internal parts and a microscopic examination performed.Confirmed: the display has turned blank due to corrosion of the electronics.A kind of liquid has entered the pen.It is not possible to use the dose memory function.The mechanical function of the pen is not affected by the faulty display.The fault is caused by accidental damage during use of the device.The pen surface is worn.Scratches or dents in surfaces are caused by normal or rough use of the device since last submission this case has been updated with the following event information updated suspect medical device expiration date added investigation result updated.Manufacturer's comment updated.Narrative updated accordingly.Manufacturer's comment/reporter's comment: 12-mar-2018: since no faults were found on the returned device novopen echo and investigation revealed that the display has turned blank due to corrosion of the electronics.It was assessed that a kind of liquid has entered the pen and hence it is not possible to use the dose memory function.The mechanical function of the pen is not affected by the faulty display.The fault is caused by accidental damage during use of the device.The pen surface is worn.Scratches or dents in surfaces are caused by normal or rough use of the device hence appear to be due to a possible user error in this case and thus not possible to find similar incidents to the one reported in argus case 580303.The drug cartridge novolog penfill was not returned for investigation.The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novolog.Continued: evaluation summary.Novopen echo - batch dv40073: the device was returned without the pen cap.Non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.Visual and functional examinations were performed.The memory display was blank and the electronic register could not be reached.Tiny scratches was observed on the dose indicator window.The function of the piston rod was found to be normal.The piston rod can move freely when no penfill cartridge is mounted in the pen and if it has not been fully retracted.When a penfill cartridge has been mounted properly in the pen, as described in the user manual for the product, the piston rod will no longer be able to move freely and the selected dose will be delivered accurately.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 dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.All mechanical functions are normal.The device was disassembled to examine internal parts and a microscopic examination performed.Confirmed: the display has turned blank due to corrosion of the electronics.A kind of liquid has entered the pen.It is not possible to use the dose memory function.The mechanical function of the pen is not affected by the faulty display.The fault is caused by accidental damage during use of the device.The pen surface is worn.Scratches or dents in surfaces are caused by normal or rough use of the device.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7225823
• MDR Text Key: 98518403
• Report Number: 9681821-2018-00005
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• 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 Catalogue Number: 185459
• Device Lot Number: DV40073
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVEMIR (INSULIN DETEMIR)
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Weight: 44