MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problems Abnormal Blood Gases (1034); Hyperglycemia (1905); Vomiting (2144); No Code Available (3191)

Event Date 06/29/2017

Event Type  Injury  

Event Description

High glucose level more that 500 mg/dl [blood glucose increased], piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin [device issue], high acetone level [blood ketone body increased], vomiting [vomiting], high level of arterial blood gases [blood gases abnormal], insulin leaked from needle around the site of injection [injection site extravasation], forgot to take his morning dose [drug dose omission].Case description: study id: (b)(6) programme.Study description: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.(b)(6).This serious solicited report from egypt was reported by a consumer as high glucose level more that 500 mg/dl" beginning on (b)(6) 2017 , "piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin" with an unspecified onset date , "high acetone level" beginning on (b)(6) 2017 , "vomiting" beginning on (b)(6) 2017 , "high level of arterial blood gases" beginning on (b)(6) 2017 , "insulin leaked from needle around the site of injection" with an unspecified onset date , "forgot to take his morning dose" with an unspecified onset date and concerned a 13 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date and ongoing due to "diabetes mellitus", actrapid penfill hm(ge) (insulin human) from unknown start date to (b)(6) 2017 due to "diabetes mellitus", insulatard penfill hm(ge) (insulin human) from unknown start date to (b)(6) 2017 due to "diabetes mellitus".Medical history included diabetes mellitus (since he was (b)(6), type not reported), headache.Concomitant medication included epifortil (non-codable).From an unknown date (reported as since 3 years), the patient was using insulatard, actrapid penfill with novopen 4 for diabetes mellitus.From an unknown date, the patient had problem with both novopen 4.It was reported that the pens did not inject insulin.As the patient sometimes adjust the dose counter to inject, the dose button presses normally and the dose the counter returns to zero.However, the insulin leaked from needle around the site of injection.Also reported that in some occasions the piston rod head got stuck in the mechanical part and does not touch the end of penfill so pen does not inject insulin and reported that this happened with two pens.The patient tried pen with new needle and new penfill.Due to problem with the pens, the patient experienced high blood glucose on (b)(6) 2017.The blood glucose value was more than 500 mg/dl.The patient was hospitalized on same day and the patient received aqua solution but the patient did not know the drugs which he received.The patient was discharged on same day as his blood glucose level was controlled.On (b)(6) 2017 at 07:00 am, the patient was again hospitalized due to vomiting, high acetone level and high level of arterial blood gases.On (b)(6) 2017 he shifted from insulatard and actrapid penfill to vial instead to control blood sugar level and last 2 hour post prandial glucose was 80 mg/dsl as he increased his dose (10u instead of 5u) because he forget to take his dose on morning.Action taken to novopen4 was not reported.Action taken to actrapid penfill hm(ge) was reported as product discontinued.Action taken to insulatard penfill hm(ge) was reported as product discontinued.On (b)(6) 2017 the outcome for the event "high glucose level more that 500 mg/dl" was reported as recovered.The outcome for the event "piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin" was unknown.The outcome for the event "high acetone level" was not reported.The outcome for the event "vomiting" was not reported.The outcome for the event "high level of arterial blood gases" was not reported.The outcome for the event "insulin leaked from needle around the site of injection" was not reported.The outcome for the event "forgot to take his morning dose" was not reported.Reporter's causality (novopen 4) - high glucose level more that 500 mg/dl: probable.Piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin: probable.High acetone level: probable.Vomiting: probable.High level of arterial blood gases: probable.Insulin leaked from needle around the site of injection: probable.Forgot to take his morning dose: probable.Company's causality (novopen 4) - high glucose level more that 500 mg/dl: possible.Piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin: possible.High acetone level: possible.Vomiting: possible.High level of arterial blood gases: possible.Insulin leaked from needle around the site of injection: possible.Forgot to take his morning dose: possible.Reporter's causality (actrapid penfill hm(ge)) - high glucose level more that 500 mg/dl: probable.Piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin: probable.High acetone level: probable.Vomiting: probable.High level of arterial blood gases: probable.Insulin leaked from needle around the site of injection: probable.Forgot to take his morning dose: probable.Company's causality (actrapid penfill hm(ge)) - high glucose level more that 500 mg/dl: possible.Piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin: possible.High acetone level: possible.Vomiting: possible.High level of arterial blood gases: possible.Insulin leaked from needle around the site of injection: possible.Forgot to take his morning dose: possible.Reporter's causality (insulatard penfill hm(ge)) - high glucose level more that 500 mg/dl: probable.Piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin: probable.High acetone level: probable.Vomiting: probable.High level of arterial blood gases: probable.Insulin leaked from needle around the site of injection: probable.Forgot to take his morning dose: probable.Company's causality (insulatard penfill hm(ge)) - high glucose level more that 500 mg/dl: possible.Piston rod head did not touch end of cartridge and got stuck in mechanical part so pen did not inject insulin: possible.High acetone level: possible.Vomiting: possible.High level of arterial blood gases: possible.Insulin leaked from needle around the site of injection: possible.Forgot to take his morning dose: possible.Suspect product: suspect medication #1: actrapid penfill hm(ge)(insulin human) solution for injection, 100 iu/ml.Suspect medication #2: insulatard penfill hm(ge)(insulin human) suspension for injection, 100 iu/ml.Dose, frequency and route used: suspect medication #1:regimen #1: 15 iu, qd, subcutaneous.Suspect medication #2 regimen #1: 10 iu, qd (5u per morning/5u per night), subcutaneous.Suspect medication #2 regimen #2: 10 iu instead of 5 iu, subcutaneous.Suspect medication #2 regimen #3: 10 iu, qd (5u per morning/5u per night), subcutaneous.

Event Description

Case description: investigation result: name: novopen 4, batch number: dug0902.The product was not returned for examination.No investigation possible.Batch trending performed.No issue identified.Name: novopen 4, batch number: unknown.The product was not returned for examination.No investigation possible.Name: actrapid penfill 3 ml 100iu/ml, batch number: fr70670.The product was not returned for examination.Name: insulatard penfill 3 ml 100iu/ml, batch number: er7m048.A reference sample check on adr/ae was found to be normal.The product was not returned for examination.Manufacturer comment: 30-aug-2017: as both novo pen 4 have not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of both suspected novopen 4 is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in (b)(4).Evaluation summary: name: novopen¿ 4, batch number: dug0902.(b)(4): the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.Batch trending performed.No issues identified.

• Brand Name: NOVOPEN 4
• 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, MEDICAL SYSTEMS; brennum park; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: novo nordisk inc.; p.o. box 846; plainsboro 08536 ; 8007276500
• MDR Report Key: 6764923
• MDR Text Key: 81787583
• Report Number: 9681821-2017-00036
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,study
• Type of Report: Initial,Followup
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2019
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: DUG0902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 13 YR
• Patient Weight: 33