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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Diabetic Ketoacidosis (2364)

Event Date 01/01/2017

Event Type  Injury  

Event Description

Diabetic ketoacidosis (dka) [diabetic ketoacidosis].High blood sugar [blood glucose increased].Pen not working [device failure].Low blood sugars [blood glucose decreased].Case description: this serious spontaneous case from the united states was reported by a nurse as "diabetic ketoacidosis (dka)" with an unspecified onset date, "high blood sugar" beginning in 2017, "pen not working" beginning in 2017, "low blood sugars" with an unspecified onset date, and concerned an adult male patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus".Patient's height, weight and body mass index (bmi) not reported.Medical history included type 1 diabetes mellitus (duration not reported).Concomitant products included - novolog penfill (insulin aspart) solution for injection, 100 u/ml.Since an unspecified date in 2017, the patient has been in the hospital due to high blood sugars (bs) over 500 mg/dl.During the first 3 episodes patient was kept for couple of days due to diabetic ketoacidosis (dka), and the last time last week (from the date of reporting) patient was only kept for few hours.It was reported that the pen was not working.On (b)(6) 2017, patient's bs was 500 mg/dl.On (b)(6) 2017, bs was 416 mg/dl, later it was 278 mg/dl for dinner and 238 mg/dl at bedtime.On (b)(6) 2018, bs was 182 mg/dl in the afternoon.On (b)(6) 2018, bs was 258 mg/dl (fasting blood sugar) and 384 mg/dl at bedtime.On (b)(6) 2018, bs was 489 mg/dl at dinner and at 6:40 pm it was 454 mg/dl and at bedtime it was 492 mg/dl and 138 mg/dl.Patient also reported blood glucose level of 48 mg/dl, 60 mg/dl and 80 mg/dl.On (b)(6) 2018, bs was 210 mg/dl morning.On (b)(6) -2018, bs was 530 mg/dl, 153 mg/dl and 116 mg/dl.On (b)(6) 2018, bs was 70 mg/dl.On an unspecified date, patient reported low blood sugars of 72 mg/dl.Patient changed the novolog cartridge, and tried 2 different cartridges.While using the novolog from the cartridge with a syringe and was able to control his blood sugar.Action taken to novopen echo was not reported.The outcome for the event "diabetic ketoacidosis (dka)" was unknown.The outcome for the event "high blood sugar" was unknown.The outcome for the event "pen not working" was not reported.The outcome for the event "low blood sugars" was unknown.Company comment: the reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novopen echo.

Event Description

Case description: concomitant products included: novolog penfill (insulin aspart) solution for injection, 100 u/ml, novofine 8mm (30g) autocover (needle) since an unspecified date in 2017, the patient has been in the hospital due to high blood sugars (bs) over 500 mg/dl.During the first 3 episodes patient was kept for couple of days due to diabetic ketoacidosis (dka), and the last time last week (from the date of reporting) patient was only kept for few hours.It was reported that the pen was not working.It was reported that patient was using novofine 30g autocover needles with the novopen echo and the novolog cartridge.Since last submission, the case has been updated with the following: novofine 30g autocover added as concomitant product.Narrative updated accordingly.

Event Description

Case description: investigation result: novopen® echo® - batch ev40063.Pen received with a penfill mounted.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.The electronic register was checked.The readout revealed indications of use of the pen with a clogged needle attached.Visual and functional examinations were performed and 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 were normal.Confirmed: the memory data in the device revealed that a number of attempted injections did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injections.After the injection to follow the attempted injection the pen will function as normal again, if a new injection needle is mounted on the pen.The observed problem is caused by unintended use of the device.The batch documentation was reviewed non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.Since last submission, the case has been updated with the following: investigation result updated.Manufacturer's comment updated.Suspect medical device expiration date added.Narrative updated.Manufacturer's comment/company comment: 14-mar-2018 :the returned novopen echo was received with a penfill mounted and on receipt it was observed that 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.The electronic register was checked and the readout revealed indications of use of the pen with a clogged needle attached.Visual and functional examinations were performed and during testing it was possible to deliver preparation from the cartridge.The results were found to comply with specifications and all mechanical functions were normal.The memory data in the device revealed that a number of attempted injections did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injections.After the injection to follow the attempted injection the pen will function as normal again, if a new injection needle is mounted on the pen.It was thus concluded that the observed problem is caused by unintended use of the device.The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of novopen echo.Evaluation summary novopen® echo® - batch ev40063.Pen received with a penfill mounted.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.The electronic register was checked.The readout revealed indications of use of the pen with a clogged needle attached.Visual and functional examinations were performed and 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 were normal.Confirmed: the memory data in the device revealed that a number of attempted injections did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injections.After the injection to follow the attempted injection the pen will function as normal again, if a new injection needle is mounted on the pen.The observed problem is caused by unintended use of the device.The batch documentation was reviewed non-conformity-related documentation examined.No irregularities recorded therefore no further action.The batch documentation has been reviewed.Nothing abnormal was found.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7230453
• MDR Text Key: 98671728
• Report Number: 9681821-2018-00006
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: EV40063
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NOVOLOG PENFILL (INSULIN ASPART); 2) NOVOFINE 8MM (30G) AUTOCOVER (NEEDLE) N/A; NOVOLOG PENFILL (INSULIN ASPART); NOVOLOG PENFILL (INSULIN ASPART)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 20 YR