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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); No Code Available (3191)

Event Date 07/23/2016

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) ketoacidosis [ketoacidosis]; hyperglycaemia (5 g/l) [hyperglycaemia]; dose not administrated due to device malfunction [device issue].This serious spontaneous case from (b)(6) was reported by a paediatrician as "ketoacidosis" with an unspecified onset date, "hyperglycaemia (5 g/l)" with an unspecified onset date, "dose not administrated due to device malfunction" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen echo red and blue (insulin delivery device) from unknown start date due to "device therapy.Information on height and weight was not reported.Medical history was not provided.Concomitant medical products: levemir penfill(insulin detemir), novorapid penfill(insulin aspart).Initial information was received from a sales rep on behalf of a physician on 18-oct-2016: a child aged of (b)(6), who was treated with both levemir penfill (insulin detemir) and novorapid penfill (insulion aspart) by using novopen echo red and blue for unknown indication.On an unknown date novopen echo red or blue malfunctioned (batch numbers: dv40212 and cv40022), therefore the dose was not injected.The patient presented with ketoacidosis with glycaemia level = 5 g/l.Suspected pens will be returned to novo nordisk for further analysis.Action taken to novopen echo red and blue was not reported.The outcome for the event "ketoacidosis" was unknown.The outcome for the event "hyperglycaemia (5 g/l)" was unknown.The outcome for the event "dose not administrated due to device malfunction" was unknown.

Event Description

Case description: this serious spontaneous case from (b)(6) was reported by a paediatrician as "ketoacidosis" beginning on (b)(6) 2016, "hyperglycaemia (5 g/l)" beginning on (b)(6) 2016, "dose not administrated due to device malfunction" beginning on (b)(6) 2016, and concerned a (b)(6) male patient who was treated with novopen echo red and blue (insulin delivery device) from unknown start date due to "type 1 diabetes".Medical history included type i diabetes mellitus (since 2015).On (b)(4) 2016, the patient was in a holiday camp in france.He had usual therapy without intercurrent infection.Novopen echo red or blue malfunctioned (batch numbers: dv40212 and cv40022), therefore the dose was not injected.The patient presented with ketoacidosis with glycaemia level 5 g/l.The post-prandial glycaemia was 3.25 g/l and ketone 0.2.The patient was hospitalised from (b)(6) 2016.The patient was recovered when the pen was changed (two pens were prescribed).The patient was received rapid insulin as corrective treatment.The causal role was assessed as possible.Action taken to novopen echo red and blue was reported as pen changed.The outcome for the event "ketoacidosis" was recovered.The outcome for the event "hyperglycaemia (5 g/l)" was recovered.The outcome for the event "dose not administrated due to device malfunction" was recovered.Suspected pens returned to novo nordisk for analysis.Investigation results: novopen echo, batch number cv40022: a batch trend report has been created.Nothing abnormal was found.The electronic register was checked.The register showed mitigation codes.A visual examination of the returned product was performed: 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 without any observed problems.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.It was not possible to observe the alleged fault on the pen's ability to deliver the pre-selected doses.All mechanical functions are 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 these 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 fault is caused by incorrect handling during use of the device.Novopen echo: batch number dv40212: a batch trend report has been created.Nothing abnormal was found.The electronic register was checked.No remarks.A visual examination of the returned product was performed: 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 without any observed problems.The product was found to be normal.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.It was not possible to observe the alleged fault on the pen's ability to deliver the pre-selected doses.All mechanical functions are normal.During test of the device it was not been possible to detect any irregularities.Since last submission of the case the following has been updated: -lab data -relevant history -investigation results -narrative updated accordingly -manufacturer's final comment.Manufacturer's final comment: on 25-nov-2016: both novopens echo have been returned to novo nordisk a/s for investigation.The investigation showed that the pens were working according to specifications and no malfunctions which could have caused the experienced adverse events were identified.The read out of one of the pens electronic register indicated that the user had tried to inject with a blocked needle attached to the pen, most likely due to needle re-use.Injecting with a blocked needle attached could lead to hyperglycaemic events.It is however stated in the instruction for use of the novopen echo that the user should always change the needle after injection and never reuse the needle.It has thus not been possible to find similar incidents to the one reported in argus case (b)(4).Evaluation summary: (b)(4): a visual examination of the returned product was performed.A batch trend report has been created.Nothing abnormal was found.(b)(4): the electronic register was checked.The register showed mitigation codes.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 without any observed problems.The dose accuracy was measured by weighing using a random penfill cartridge.The results were found to comply with specifications.It was not possible to observe the alleged fault on the pen's ability to deliver the pre-selected doses.All mechanical functions are normal.Please be aware that it is important to use a new needle for each injection.The needle should be mounted immediately before the injection.Always remove the used needle immediately after each injection and store the device without a needle attached.Otherwise, clogging of the needle may occur.Finally, priming must always be performed before each injection, as stated in the package leaflet.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 these 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 fault is caused by incorrect handling during use of the device.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, 3400 ; DA 3400
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd, 2880 ; DA 2880
• Manufacturer Contact: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 6090619
• MDR Text Key: 59555660
• Report Number: 9681821-2016-00036
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/04/2015
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: CV40022
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LEVEMIR PENFILL (INSULIN DETEMIR) SOL FOR INJ; NOVORAPID PENFILL (INSULIN ASPART) SOL FOR INJ
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 7 YR