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

Model Number N/A

Device Problems Break (1069); No Flow (2991)

Patient Problems Diarrhea (1811); Malaise (2359); Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Sickness [malaise], diarrhea [diarrhoea], diabetic ketoacidosis [diabetic ketoacidosis], cartridge holders had failed and stopped letting out insulin [device failure], pen was broken [device breakage].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "sickness" with an unspecified onset date, "diarrhea" with an unspecified onset date, "diabetic ketoacidosis" with an unspecified onset date, "cartridge holders had failed and stopped letting out insulin" with an unspecified onset date, "pen was broken" with an unspecified onset date, and concerned a female patient (age not reported) who was treated with novopen echo (insulin delivery device) from unknown start date due to "device therapy", novopen echo (insulin delivery device) from unknown start date due to "device therapy", novorapid penfill (insulin aspart) from unknown start date due to "drug use for unknown indication" (dose and frequency unknown).Patient's height,weight and body mass index were not reported.Medical history included type 1 diabetes mellitus (duration not reported) concomitant products included - needle, unspecified (needle).On an unspecified date, the patient developed sickness, diarrhea and was hospitalised due to faulty pens.The cartridge holder of one pen had failed and stopped letting out insulin.The other pen was broken.On an unknown date the patient experienced diabetic ketoacidosis.Batch number of novopen echo and novorapid was available.Action taken to novopen echo was not reported.Action taken to novopen echo was not reported.Action taken to novorapid penfill was not reported.The outcome for the event "sickness" was not reported.The outcome for the event "diarrhea" was not reported.The outcome for the event "diabetic ketoacidosis" was not reported.The outcome for the event "cartridge holders had failed and stopped letting out insulin" was not reported.The outcome for the event "pen was broken" was not reported.Reporter comment: the patient did not change the needle after every injection and stored the device with needle attached.

Event Description

Case description: investigation results: name: (b)(6) batch number: dug2054 the device was returned with the cartridge from this case 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.No remarks visual and functional examinations were performed.The cartridge holder worked normally 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 test result was within the specification.It was not possible to detect the alleged fault.The product was found to be normal.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Name: novopen echo batch number: dug1775 the electronic register was checked.No remarks.A visual examination of the returned product was performed.It is not possible to examine the pen for dose accuracy as the cartridge holder is cracked at both sides of snap.Confirmed 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.The fault is caused by an error in novo nordisk a/s name: novorapid penfill 3 ml batch number : gr78313 a visual examination of the returned product was performed.Due to insufficient complaint sample material no further investigation was performed.Parameters identity, assay and degradation were examined.A ph analysis was also performed.A reference were examined macroscopically.Parameters identity, assay and degra-dation were also performed.The reference sample was found to be normal.The results were found to comply with specifications.During investigation it has not been possible to detect any irregularities related to the complaint on a reference/retain sample of the batch in question.All the results were as expected and within acceptable limits.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal since last submission, the case has been updated with the below information -other relevant history updated -investigation results updated.-manufacturing comment updated.-narrative updated accordingly.Manufacturer comment: 28-feb-2019: "the patient was hospitalised with diarrhoea and diabetic ketoacidosis.The two suspected novopen echo were returned to novo nordisk for investigation.The cartridge holder of the first pen was damaged in a way which could influence the dose accuracy of the pen (deliver lesser insulin than intended).The second pen worked in accordance to set specifications, but showed signs that the user had left the needle attached to the pen in between injections and neglected to check the drug flow before injection.This could lead to the patient receiving lesser insulin than intended and thus to a hyperglycaemic event.Both pens belongs to batches encompassed by the fsca #20170609 related to novopen echo and novopen 5 cartridge holder and the damaged cartridge holder on the first novopen echo is related to the fsca.Although the damaged cartridge holder could cause the patient to experience a hyperglycaemic event it is judged that both the diarrhoea and the user error would have contributed to the development of diabetic ketoacidosis".Diabetic ketoacidosis is listed; malaise and diarrhoea are assessed as unlisted.Patient's underlying medical condition of type 1 diabetes mellitus is a significant risk factor for diabetic ketoacidosis.Malaise and diarrhoea are initial presentation of ketoacidois.This single case is not considered to change the safety profile of novorapid penfill.H3 continued: evaluation summary name: novopen echo batch number: dug2054 the device was returned with the cartridge from this case 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.No remarks visual and functional examinations were performed.The cartridge holder worked normally 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 test result was within the specification.It was not possible to detect the alleged fault.The product was found to be normal.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 ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 8289808
• MDR Text Key: 134503209
• Report Number: 9681821-2019-00007
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/06/2016
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: DUG2054
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 00000-7/3/17-001-R
• Patient Sequence Number: 1
• Treatment: NEEDLE, UNSPECIFIED (NEEDLE) N/A; NEEDLE, UNSPECIFIED (NEEDLE) N/A
• Patient Outcome(s): Hospitalization