MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Break (1069); Mechanical Problem (1384); Device Inoperable (1663); Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Hyperglycaemia reaching 600 mg/dl [hyperglycaemia], novopen 3 is stuck in the mechanical part of the pen [device issue], pen didn't inject insulin [device failure].Case description: study (b)(6).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 (b)(6) was reported by a consumer as "hyperglycaemia reaching 600 mg/dl" beginning on (b)(6) 2015 , "novopen 3 is stuck in the mechanical part of the pen" with an unspecified onset date and "pen didn't inject insulin" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen 3 (insulin delivery device) from unknown start date due to "diabetes mellitus"and mixtard 30 penfill hm(ge) (insulin human) 75 u, qd (30 u morning, 45 units night), from unknown start date and ongoing due to "diabetes mellitus".Medical history included diabetes mellitus (type not reported, duration 22 years) and hypertension (duration 10 years).Concomitant medications included - concor (bisoprolol fumarate).According to the reporter (who is a consumer and son of the patient) the patient stated that the pen was having problem.The piston rod was struck in the mechanical part of the pen and the pen did not inject insulin.On (b)(6) 2015, the patient was hospitalized due to hyperglycemia and his blood glucose reached 600 mg/dl.The patient stayed in hospital for 10 days.On (b)(6) 2015, the patient recovered and was discharged from hospital.Training in pen was done but the problem still existed.Action taken to novopen 3 was not reported.Action taken to mixtard 30 penfill hm(ge) was not reported.On (b)(6) 2015 the outcome for the event "hyperglycaemia reaching 600 mg/dl" was recovered.The outcome for the event "novopen 3 is stuck in the mechanical part of the pen" was not yet recovered.The outcome for the event "pen didn't inject insulin" was not yet recovered.Reporter's causality ( novopen 3) - hyperglycaemia reaching 600 mg/dl : probable, novopen 3 is stuck in the mechanical part of the pen : probable, pen didn't inject insulin : probable.Company's causality ( novopen 3) - hyperglycaemia reaching 600 mg/dl : unlikely, novopen 3 is stuck in the mechanical part of the pen : possible, pen didn't inject insulin : possible.Reporter's causality ( mixtard 30 penfill hm(ge)) - hyperglycaemia reaching 600 mg/dl : probable, novopen 3 is stuck in the mechanical part of the pen : probable, pen didn't inject insulin : probable.Company's causality ( mixtard 30 penfill hm(ge)) - hyperglycaemia reaching 600 mg/dl : unlikely, novopen 3 is stuck in the mechanical part of the pen : possible, pen didn't inject insulin : possible.

Event Description

Case description: investigation result: name: novopen 3 - batch unknown.No investigation was possible, because neither sample nor batch number was available.Name: mixtard 30 hm penfill - batch fr7x137.The product was not returned for examination.The batch documentation has been reviewed.Nothing abnormal was found.Company comment: 25-sep-2017: as the device (novopen 3) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device 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 argus case 558390.In the light of available information that the patient was not able to receive insulin due to the device, the sponsor assesses the event 'hyperglycaemia' unlikely related to the suspected drug mixtard 30.The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 penfill hm(ge).Evaluation summary: name: novopen 3 - batch unknown.No investigation was possible, because neither sample nor batch number was available.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycaemia reaching 300 mg/dl [hyperglycaemia] novopen 3 is stuck in the mechanical part of the pen [device issue] pen didn't inject insulin [device failure] needles are used for over two weeks [multiple use of single-use product] patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose [wrong technique in device usage process] case description: study description: trial title: 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.Patient's bmi: (b)(6).This serious solicited report from egypt was reported by a consumer as "hyperglycaemia reaching 300 mg/dl" beginning on 08-aug-2015 , "novopen 3 is stuck in the mechanical part of the pen" with an unspecified onset date , "pen didn't inject insulin" with an unspecified onset date , "needles are used for over two weeks" with an unspecified onset date , "patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose" with an unspecified onset date and concerned a 72 years old male patient who was treated with novopen 3 (insulin delivery device) from unknown start date (4 years ago) due to "type 2 diabetes mellitus ", mixtard 30 penfill hm(ge) (insulin human) 75 u, qd (30 u morning, 45 units night) from unknown start date (4 years ago) and ongoing due to "type 2 diabetes mellitus ", medical history included type 2 diabetes mellitus (duration 22 years) and hypertension (duration10 years).On 08-aug-2015, the patient was hospitalized due to hyperglycemia and his blood glucose reached 300 mg/dl.The patient stayed in hospital for 10 days.The patient uses already used needle for over two weeks and leaves the needle attached to the pen in between injections.The force needed to inject felt different from normal and was more difficult.The patient re-suspends the mixtard 30 penfill before use.Additonally, the patient used the dialling clicks to estimate the dose of the insulin.The patient didnot change diet or exercise level prior to the events.On 18-aug-2015 the outcome for the event "hyperglycaemia reaching 300 mg/dl" was recovered.The outcome for the event "novopen 3 is stuck in the mechanical part of the pen" was not yet recovered.The outcome for the event "pen didn't inject insulin" was not yet recovered.The outcome for the event "needles are used for over two weeks" was not reported.The outcome for the event "patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose" was not reported.Reporter's causality (novopen 3) - hyperglycaemia reaching 300 mg/dl : probable novopen 3 is stuck in the mechanical part of the pen : probable pen didn't inject insulin : probable needles are used for over two weeks : unknown patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose : unknown company's causality (novopen 3) - hyperglycaemia reaching 300 mg/dl : unlikely novopen 3 is stuck in the mechanical part of the pen : possible pen didn't inject insulin : possible needles are used for over two weeks : possible patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose : possible reporter's causality ( mixtard 30 penfill hm(ge)) - hyperglycaemia reaching 300 mg/dl : probable novopen 3 is stuck in the mechanical part of the pen : probable pen didn't inject insulin : probable needles are used for over two weeks : unknown patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose : unknown company's causality ( mixtard 30 penfill hm(ge)) - hyperglycaemia reaching 300 mg/dl : unlikely novopen 3 is stuck in the mechanical part of the pen : possible pen didn't inject insulin : possible needles are used for over two weeks : possible patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose : possible since last submission, the case has been updated with the following: -medical history updated from diabetes mellitus to type 2 diabetes mellitus -patient bmi updated -lab data updated -new events "needles are used for over two weeks" and "patient leaves needle attached to the pen between injections and used dialling clicks to estimate the insulin dose" added -event verbatim changed from "hyperglycaemia reaching 600mg/dl" to "hyperglycaemia reaching 300mg/dl" -product started 4 years ago added -device codes updated -narrative updated accordingly -reporter's comment added reporter comment: no hcp contact is provided so no medical causality assessment is obtained.

• Brand Name: NOVOPEN 3
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 6841240
• MDR Text Key: 84626166
• Report Number: 9681821-2017-00048
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 19-938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,study
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONCOR (BISOPROLOL FUMARATE) , 5 MG ONGOING; CONCOR (BISOPROLOL FUMARATE) , 5 MG ONGOING
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 75