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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); Bradycardia (1751); Hyperglycemia (1905); Swelling (2091); Cognitive Changes (2551); No Code Available (3191)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

See file attachment for complete response to fda request of february 1, 2018 regarding report number mw5071864 - attachment: [nn response to fda rfi re report number mw5071864.Pdf].

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Heart rate dropped to 36 beats per minute [heart rate decreased].Irregular heart beat [heart rate irregular].Swelling in legs [peripheral swelling].Swelling in feet [peripheral swelling].Glycosylated hemoglobin levels were consistently 9% [glycosylated haemoglobin increased].Difficulty controlling blood glucose [diabetes mellitus inadequate control].Difficulty concentrating [disturbance in attention].Products under delivered insulin [incorrect dose administered by device].Products malfunctioned [device malfunction].Case description: this serious spontaneous regulatory authority case from the united states received via fda (us food and drug administration), usa was reported by a consumer as "heart rate dropped to 36 beats per minute" beginning on 2017 (before (b)(6) 2017) , "irregular heart beat" beginning on (b)(6) 2017, "swelling in legs" beginning on 2016, "swelling in feet" beginning on 2016, "glycosylated hemoglobin levels were consistently 9%" beginning on (b)(6) 2016, "difficulty controlling blood glucose" beginning on (b)(6) 2016, "difficulty concentrating" beginning on (b)(6) 2016, "products under delivered insulin" beginning on (b)(6) 2016, "products malfunctioned" beginning on (b)(6) 2016 and concerned a (b)(6) years old male patient who was treated with novopen echo (insulin delivery device) from (b)(6) 2017 and ongoing due to "type 2 diabetes mellitus", novopen 3 (insulin delivery device) (reported as novopenâ® 3 dial-a-dose insulin delivery device) from unknown start date to (b)(6) 2017 due to "type 2 diabetes mellitus" and novolog penfill (insulin as part) from unknown start date (about 10 years ago) and ongoing due to "type 2 diabetes mellitus" (regimen # 1: unknown dose and frequency with therapy dates unknown start date to (b)(6) 2017, regimen # 2: 6 u, tid with therapy dates (b)(6) 2017 to 2017, regimen # 3: 6 u, tid with therapy dates (b)(6) 2017 to ongoing).Patient's height, weight and body mass index: not reported.Medical history included type 2 diabetes mellitus for past 35 years (since 1982 and ongoing), kidney transplant in 2004, vision not good since 2007 and ongoing, several surgeries, eye laser surgery, vitreous surgery and eye lens replacement surgery.Concomitant product included novofine (needle).Treatment included furosemide (furosemide).A patient reported that his glycosylated hemoglobin a1c levels were consistently 9%, had difficulty controlling blood glucose levels and difficulty concentrating due to under delivered insulin as a result of product malfunction while receiving therapy with novolog penfill cartridge (unknown batch) via novopen 3 (unknown batch) beginning on (b)(6) 2016.The patient had not received any treatment.On an unspecified date in 2016, the patient developed swelling in the legs and feet.The patient was treated with furosemide for the swelling but it was not effective.Additionally, the patient used compression stockings and had lymphatic massage performed but they were also not effective.On (b)(6) 2017, the patient discontinued novopen 3 and began using novopen echo (batch fvg7458-3) with novolog penfill cartridge (batch fs61j37).The patient continued to experience glycosylated hemoglobin levels that were consistently 9%, difficulty controlling blood glucose levels and difficulty concentrating due to under delivered insulin as a result of product malfunction.On an unspecified date in 2017 (before (b)(6) 2017), the patient's heart rate dropped to 36 beats per minute.On (b)(6) 2017, the patient had an irregular heart beat.The patient was placed on heart monitoring.The patient mentioned his heart doctor and endocrinologist were concerned about his heart and kidneys, respectively.On an unspecified date in (b)(6) 2017, the patient switched to another novolog penfill cartridge (batch fs61e89) and novopen echo (batch fvga926-2) but the events have been ongoing.Action taken to novopen echo was reported as no change.Action taken to novopen 3 was reported as product discontinued.Action taken to novolog penfill was reported as no change.The outcome for the event "heart rate dropped to 36 beats per minute" was not recovered.The outcome for the event "irregular heart beat" was not recovered.The outcome for the event "swelling in legs" was not recovered.The outcome for the event "swelling in feet" was not recovered.The outcome for the event "glycosylated hemoglobin levels were consistently 9%" was not recovered.The outcome for the event "difficulty controlling blood glucose" was not recovered.The outcome for the event "difficulty concentrating" was not recovered.The outcome for the event "products under delivered insulin" was not recovered.The outcome for the event "products malfunctioned" was not recovered.The patient felt that all the events were related to the use of novo nordisk suspect products.This case was merged from argus case (b)(6).The future case reference hereafter is argus case (b)(6).This case is combined initial and final medical device report.Investigation results: name: novopenâ® echoâ® - batch fvg7458-3.The suspected pen is part of the affected batches involved in the recall (novo nordisk internal reference # (b)(4)).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.The cartridge holder is normal.The dose accuracy was measured by weighing.The results were found to comply with specifications.The electronic register was checked.No remarks observed.During examination and test of the product it has not been possible to detect any irregularities.The product was found to be normal.Name: novopenâ® echoâ® - batch fvga926-2.No investigation possible as no sample available.Name: novopenâ® 3 dial-a-dose insulin delivery device - batch unknown.No investigation was possible, because neither sample nor batch number was available.Manufacturer comment: the patient ((b)(6)), who was diagnosed with type ii diabetes mellitus in 1982 was using 3 different devices reported as suspected products in this case.Events related to the use of novopen 3 were reported in 2016, the other events related to heart beat were reported while used 2 different novopen echo pens were reported in 2017.Heart rate decreased, heart rate irregular, swelling of feet and legs and difficulty concentrating are unlisted events according to the novo nordisk company core data sheet (ccds) for novolog.A medical history of type 2 diabetes mellitus which has been associated with an increased risk for cardiovascular disease considered a confounder.In light of that the patient had type ii diabetes mellitus for the past 35 years it is plausible that events are related to the disease.Limited information as related concomitant medications, family or social history, and laboratory/diagnostic evaluations limits further medical assessment.One novopen echo was sent for the investigation.Since no faults were found on the returned novopen echo and only very limited information regarding the patient's handling of suspected product is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in argus case (b)(6).Another novopen echo and novopen 3 were not sent for the investigation.This single case report is not considered to change the current knowledge of the safety profile of the products.Reporter comment: the patient felt that all the events were related to the use of novo nordisk suspect products.Evaluation summary: novopenâ® 3 dial-a-dose insulin delivery device: batch number: unknown.No investigation was possible, because neither sample nor batch number was available.

Event Description

[preferred term] (related symptoms if any separated by commas).Heart rate dropped to 36 beats per minute [heart rate decreased].Irregular heart beat [heart rate irregular].Swelling in legs [peripheral swelling].Swelling in feet [peripheral swelling].Difficulty concentrating [disturbance in attention.] glycosylated hemoglobin levels were consistently 9% [glycosylated haemoglobin increased].Difficulty controlling blood glucose [diabetes mellitus inadequate control].Products under delivered insulin [incorrect dose administered by device].Products malfunctioned [device malfunction].Case description: this serious spontaneous regulatory authority case from the united states received via fda (us food and drug administration), usa was reported by a consumer as "heart rate dropped to 36 beats per minute" beginning on 2017, "irregular heart beat" beginning on jul-2017, "swelling in legs" beginning on 2016, "swelling in feet" beginning on 2016, "difficulty concentrating" beginning on (b)(6) 2016, "glycosylated hemoglobin levels were consistently 9%" beginning on (b)(6) 2016, "difficulty controlling blood glucose" beginning on (b)(6) 2016, "products under delivered insulin" beginning on (b)(6) 2016, "products malfunctioned" beginning on (b)(6) 2016 and concerned a 67 years old male patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus", novopen 3 (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus", , novolog penfill (insulin aspart) from unknown start date (about 10 years ago) and ongoing due to "type 2 diabetes mellitus" (regimen # 1: unknown dose and frequency with therapy dates unknown start date to mar-2017, regimen # 2: 6 u, tid with therapy dates mar-2017 to 2017, regimen # 3: 6 u, tid with therapy dates aug-2017 to ongoing).It was reported that, the patient wore an event monitor for 8 days and 19 hours starting on (b)(6) 2017.It revealed an average heart rate of 79 beats per minute (bpm) (range 59- 115 bpm) there were multiple episodes of type 1 second degree av block.There was 1 run of svt (supraventricular tachycardia) at 130 bpm.There were frequent pvc's (premature ventricular contractions).The patient was asymptomatic on the monitor.Since last submission, the following has been updated: lab data updated with type 1 second degree av block, 1 run of svt (supraventricular tachycardia) at 130 bpm and frequent pvc's (premature ventricular contractions).Manufacturer comment updated.Narrative updated.Furthermore, a correction was made.Since last submission of the case, on 13-jun-2018 the following has been corrected: evaluation conclusion code.Manufacturer comment: the patient (67), who was diagnosed with type ii diabetes mellitus in 1982 was using 3 different devices reported as suspected products in this case.Events related to the use of novopen 3 were reported in 2016, the other events related to heart beat were reported while used 2 different novopen echo pens were reported in 2017.Heart rate decreased, heart rate irregular, swelling of feet and legs and difficulty concentrating are unlisted events according to the novo nordisk company core data sheet (ccds) for novolog.The underlying cardiac monitoring investigations showing features of type 1 second degree av block, 1 run of svt (supraventricular tachycardia) at 130 bpm and frequent pvc's (premature ventricular contractions) can explain the events of heart rate decreased and heart rate irregular in this patient.A medical history of type 2 diabetes mellitus which has been associated with an increased risk for cardiovascular disease considered a confounder.In light of that the patient had type ii diabetes mellitus for the past 35 years it is plausible that events are related to the disease.Limited information as related concomitant medications, family or social history limits further medical assessment.One novopen echo was sent for the investigation.Since no faults were found on the returned novopen echo and only very limited information regarding the patient's handling of suspected product is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in argus case: (b)(4).Another novopen echo and novopen 3 were not sent for the investigation.This single case report is not considered to change the current knowledge of the safety profile of the products.

• Brand Name: NOVOPEN 3
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7321152
• MDR Text Key: 101841657
• Report Number: 9681821-2018-00020
• 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
• Type of Report: Initial,Followup
• Report Date: 09/13/2017
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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: 05/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1) NOVOFINE (NEEDLE) N/A
• Patient Outcome(s): Other
• Patient Age: 67 YR