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

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

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

Event Date 07/28/2016

Event Type  Injury  

Event Description

Irregular heart beats [heartbeats irregular].Coma; blood glucose reached to -high- on glucometer [diabetic hyperglycaemic coma] big problem in his wife novopen 4 which lead to get in comma and enter hospital [device malfunction].Inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin [incorrect dose administered by device].Study id: (b)(6)-outbound patient calls.Study description: trial title: the objective of the programme is to perform outbound calls to the patients who have received samples of novo nordisk (b)(4) products.This is to confirm that they have received the sample, and verify if they have any problems with regard to the product received, or any problem with regard to diabetes (b)(6).This serious solicited report from (b)(6) was reported by a consumer as "irregular heart beats" beginning on (b)(6) 2016 , "coma; blood glucose reached to -high- on glucometer" beginning on (b)(6) 2016 , "big problem in his wife novopen 4 which lead to get in coma and enter hospital" with an unspecified onset date , and "inaccurate dose being injected by the pen (the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin" with an unspecified onset date and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from and to unknown dates due to "type 2 diabetes mellitus".Medical history included type 2 diabetes mellitus, hypertension, rheumatoid arthritis, and hypercholesterolaemia.Concomitant medications included - mixtard 30 hm penfill (insulin human) solution for injection 100 iu/ml therapy dates:(b)(6) 2014 to (b)(6) 2016.Treatment medications included - potassium (potassium) and other solutions.The patient's husband reported that there was a big problem in his wife's novopen 4 which lead to a coma and admission to hospital due to inaccurate dose being injected by the pen (the pen injected 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin on (b)(6) 2016.The diagnosis were according to patient's husband "blood acids and gases and irregular heart beat".The patient's husband reported that his wife's blood glucose reached to "high" on glucometer before the coma.After stopping the pen and use vial form her blood glucose became controlled three weeks ago.The patient was discharged from hospital on (b)(6) 2016.Action taken to novopen 4 was reported as product discontinued.On an unknown date the outcome for the event "irregular heart beats" was recovered.On an unknown date the outcome for the event "coma; blood glucose reached to -high- on glucometer" was recovered.The outcome for the event "big problem in his wife novopen 4 which lead to get in comma and enter hospital" was not reported.The outcome for the event "inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin" was not reported.Reporter's causality ( novopen 4): irregular heart beats : possible; coma; blood glucose reached to -high- on glucometer : possible; big problem in his wife novopen 4 which lead to get in comma and enter hospital : unknown; inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin : unknown.Company's causality ( novopen 4): irregular heart beats : unlikely; coma; blood glucose reached to -high- on glucometer : possible; big problem in his wife novopen 4 which lead to get in comma and enter hospital : possible; inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin : possible.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Diabetic ketoacidosis [diabetic ketoacidosis] big problem in his wife novopen 4 which lead to get in comma and enter hospital [device malfunction], inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin [incorrect dose administered by device], coma; blood glucose reached to -high- on glucometer [diabetic hyperglycaemic coma].This serious solicited report from egypt was reported by a consumer as "irregular heart beats" beginning on (b)(6) 2016 , "diabetic ketoacidosis" beginning on (b)(6) 2016 , "big problem in his wife novopen 4 which lead to get in comma and enter hospital" with an unspecified onset date , "inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin" with an unspecified onset date , "coma; blood glucose reached to -high- on glucometer" beginning on (b)(6) 2016 and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from (b)(6) 2014 to an unknown date due to "type 2 diabetes mellitus".Concomitant medications included - mixtard 30 hm penfill (insulin human) suspension for injection 100 iu/ml (b)(6) 2014 to (b)(6) 2016 , cidophage (metformin hydrochloride) ongoing, vitamin b nos (vitamin b nos), aspirin (acetylsalicylic acid).The patient also used bizocard 5 ml oral once for hypertension, which the patient started 6 years ago, hydrokin oral twice daily, asposid oral once daily both which the patient started 3 years ago and ongoing for rheumatoid arthritis and ciotex for neuropathy oral tablets once daily also started 3 years ago and ongoing (not able to be coded).It was also reported, that the patient was taking a yellow ampule 3 years ago for rheumatoid arthritis and now replaced by 6 tablets took together once a week.It was reported that the device stopped working around a week before the event.The time of the last dose of the product prior to the event was unknown.The patient's injected by the pen (the pen injected 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin on (b)(6) 2016.The diagnosis were according to patient's husband "blood acids and gases and irregular heart beat".The patient's husband reported that his wife's blood glucose reached to "high" on glucometer before the coma.However it was also reported, that the diagnosis was diabetic ketoacidosis.After stopping the pen and use vial form her blood glucose became controlled three weeks ago.The patient was discharged from hospital on (b)(6) 2016.The blood glucose level at the time of the event was unknown.The results of previous and latest tests were not available.The patient had no recent episodes of hyperglycaemia.The patient in general reused the needles and left the needle attached to the pen in between injections.The patient did re-suspend before use.The patient did not use dialling clicks to estimate the dose of the insulin but by the number appearing on the scale.The patient had been trained by novocare educators.The patient had not recently changed your diet or exercise level and stored the insulin in use at room temperature 20-25 degrees celsius.The patient had not recently changed from another novopen to the current novopen.Action taken to novopen 4 was reported as product discontinued.The outcome for the event "irregular heart beats" was recovered.The outcome for the event "diabetic ketoacidosis" was recovered.The outcome for the event "big problem in his wife novopen 4 which lead to get in comma and enter hospital" was recovered.The outcome for the event "inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin" was recovered.The outcome for the event "coma; blood glucose reached to -high- on glucometer" was recovered.Reporter's causality ( novopen 4) - irregular heart beats: possible.Diabetic ketoacidosis: possible.Big problem in his wife novopen 4 which lead to get in comma and enter hospital : unknown.Inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin : unknown.Coma; blood glucose reached to -high- on glucometer : unknown.Company's causality (novopen 4) - irregular heart beats: unlikely.Diabetic ketoacidosis: possible.Big problem in his wife novopen 4 which lead to get in comma and enter hospital : possible.Inaccurate dose being injected by the pen(the pen inject 20 unit out of 50 unit adjusted dose) with mixtard 30 insulin: possible.Coma; blood glucose reached to -high- on glucometer: possible.Name: novopen, batch number: fvg7227-1, a batch trend report was created.Nothing abnormal was found.The product was not returned for examination.The complaint was registered in the novo nordisk complaint handling system.Since last submission the following has been updated: -additional event added diabetic ketoacidosis.-relevant history -outcome of events -concomitant medication and treatment medication -detailed course of event -investigational result -narrative.Manufacturer comment: on 27-sep-2016 as novo pen 4 has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected novo pen 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 argus case (b)(4).Evaluation summary: name: novopen, batch number: fvg7227-1 (b)(4): a batch trend report has been created.Nothing abnormal was found.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.The complaint has been registered in the novo nordisk complaint handling system.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 5954092
• MDR Text Key: 54879985
• Report Number: 9681821-2016-00031
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: FVG7227-1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• 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: MIXTARD 30 HM PENFILL (INSULIN HUMAN) 100 IU/ML
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 41 YR
• Patient Weight: 71