MAUDE Adverse Event Report: NOVO NORDISK A/S, NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Defective Device (2588)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Syncope/Fainting (4411)

Event Type  Injury  

Event Description

Patient almost died [near death experience].Sugar levels to be all over the place (hypos and hypers) [diabetes mellitus inadequate control].Faulty pens, jamming part way through, which are stopping and starting [device malfunction].Infection due to the fact that patient was not receiving correct amount of insulin [infection].Case description: this serious spontaneous case from the united kingdom was reported by a consumer as "patient almost died(near death experience)" with an unspecified onset date, "sugar levels to be all over the place (hypos and hypers)(loss of control of blood sugar)" with an unspecified onset date, "faulty pens, jamming part way through, which are stopping and starting(device malfunction)" with an unspecified onset date, "infection due to the fact that patient was not receiving correct amount of insulin(infection)" with an unspecified onset date, and concerned a (b)(6)-year-old female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", tresiba flextouch u200 (insulin degludec) solution for injection, 100 iu/ml (dose, frequency & route used: unk, unknown) from unknown start date for "product used for unknown indication", tresiba flextouch u200 (insulin degludec) from unknown start date for "product used for unknown indication", tresiba penfill (insulin degludec) from unknown start date for "product used for unknown indication".Medical history was not provided.Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml on an unspecified date, the patient had faulty pens, jamming part way through, which are stopping and starting and did not appear to be working.As a result, the patient's blood sugar levels to be all over the place (hypos and hypers), unit and reference range were not reported.The patient also experienced an infection which was down to the fact that the patient was not receiving sufficient insulin.It was also reported that, the products almost killed patient.Batch numbers: novopen 5: kvgy043-1.Tresiba flextouch u200: kzfm803.Tresiba flextouch u200: kzfr092.Tresiba penfill: ls6dh78.Action taken to tresiba flextouch u200 was not reported.Action taken to tresiba flextouch u200 was not reported.Action taken to tresiba penfill was not reported.The outcome for the event "patient almost died(near death experience)" was recovered.The outcome for the event "sugar levels to be all over the place (hypos and hypers)(loss of control of blood sugar)" was not reported.The outcome for the event "faulty pens, jamming part way through, which are stopping and starting(device malfunction)" was not reported.The outcome for the event "infection due to the fact that patient was not receiving correct amount of insulin(infection)" was not reported.This case was re-classified from nonserious to serious on (b)(6) 2021 due to the event "patient almost died".Preliminary manufacturer's comment: 13-jul-2021: the suspected device (novopen 5) has been returned to novo nordisk for evaluation.It revealed that the cap, with the cartridge holder inside separated from the pen body.Investigation is ongoing, no conclusion is reached.13-jul-2021:the suspected device (tresiba flextouch) has been returned to novo nordisk for evaluation.Investigation is ongoing, no conclusion is reached.Company comment: the event "near death experience" is assessed as unlisted; diabetes mellitus inadequate control is assessed as listed according to the novo nordisk current ccds in tresiba flextouch.Relevant information on medical history, final diagnosis, product investigation results, action taken with tresiba flextouch are unavailable for complete causality assessment.This single case report is not considered to change the current knowledge of the safety profile of tresiba flextouch."this report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo".

Event Description

The current location of tresiba flextouch u200: kzfm803 and kzfr092 (prefilled pens) was novonordisk a/s the period of use of tresiba flextouch u200: kzfm803 and kzfr092 (prefilled pens) was unknown.Action taken to novopen 5 was reported as product discontinued due to ae.Action taken to tresiba flextouch u200 was reported as product discontinued due to ae.Action taken to tresiba flextouch u200 was reported as product discontinued due to ae.Action taken to tresiba penfill was reported as product discontinued due to ae.Investigation result: tresiba® flextouch (u200) - batch kzfm803.Visual examination and functional testing were performed.The returned device was found to function normally.When using a new needle there was no problem in using the device.The dose accuracy was measured by weighing.The results were found to comply with specifications.Furthermore, a reference sample was examined macroscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.The complaint samples have been analysed chemically including ph.The result was within acceptable limits.During examination of the product, no irregularities related to the complaint were detected.Tresiba flextouch (u200) - batch kzfr092.Visual examination and functional testing were performed.The returned device was found to function normally.When using a new needle there was no problem in using the device.The dose accuracy was measured by weighing.The results were found to comply with specifications.Furthermore, a reference sample was examined macroscopically and analysed chemically.The reference sample was found to be normal.The results were found to comply with specifications.The complaint samples have been analysed chemically including ph.The result was within acceptable limits.During examination of the product, no irregularities related to the complaint were detected.Tresiba penfill (u100) - batch ls6dh78.A visual examination of the returned products was performed.One of the returned cartridges was tested with a novopen echo with a new novo nordisk needle mounted.During testing it was possible to deliver preparation from the cartridge.A complaint sample was also analysed chemically including ph.The result was within acceptable limits.In conclusion, during examination of the product, no irregularities related to the complaint were detected.Novopen 5 - batch kvgy043-1.A visual examination of the returned product was performed.The device was returned in 2.The cap, with the cartridge holder inside separated from the pen body.If the cartridge holder is stuck in the pen cap it was not possible to mount the cartridge holder to the pen because it would turn around inside the cap.The electronic register was checked.No remarks.Visual examination and functional testing were performed and 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 dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Since last submission, the case was updated with the following: -action taken with suspect products updated from not reported to product discontinued due to ae.-investigation result updated.-device tab, med watch tab, eu/ca tab and device addendum tab updated.-narrative updated accordingly.Final manufacturer's comment: 26-jul-2021: the suspected device (novopen 5) has been returned to novo nordisk for evaluation.Preliminary examination revealed that the cap, with the cartridge holder inside separated from the pen body.The detailed investigation of the device showed that it was working in accordance to specifications.No confounding factors.It is therefore not possible to identify a clear root cause in relation to the functionality of the pen.26-jul-2021:the suspected device (tresiba flextouch, batch no.Kzfr092 and kzfm803) has been returned to novo nordisk for evaluation.Since no faults were found on the returned device tresiba flextouch and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event.No confounding factors.Company comment: the event "near death experience" is assessed as unlisted; diabetes mellitus inadequate control is assessed as listed according to the novo nordisk current ccds in tresiba flextouch.Relevant information on medical history, final diagnosis, action taken with tresiba flextouch are unavailable for complete causality assessment.Of note, product investigation, no irregularities related to the complaint were detected.This single case report is not considered to change the current knowledge of the safety profile of tresiba flextouch."this report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo".H3 continued: evaluation summary: novopen 5 - batch kvgy043-1.A visual examination of the returned product was performed.The device was returned in 2.The cap, with the cartridge holder inside separated from the pen body.If the cartridge holder is stuck in the pen cap it was not possible to mount the cartridge holder to the pen because it would turn around inside the cap.The electronic register was checked.No remarks.Visual examination and functional testing were performed and 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 dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) patient almost died (collapsed) [syncope] sugar levels to be all over the place (hypos and hypers) [diabetes mellitus inadequate control] faulty pens, jamming part way through, which are stopping and starting [device malfunction] infection due to the fact that patient was not receiving correct amount of insulin [infection] this serious spontaneous case from the united kingdom was reported by a consumer as "patient almost died (collapsed)(syncope)" with an unspecified onset date, "sugar levels to be all over the place (hypos and hypers)(loss of control of blood sugar)" with an unspecified onset date, "faulty pens, jamming part way through, which are stopping and starting(device malfunction)" with an unspecified onset date, "infection due to the fact that patient was not receiving correct amount of insulin(infection)" with an unspecified onset date, and concerned a 73-year-old female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy", tresiba flextouch u200 (insulin degludec) from unknown start date for "product used for unknown indication", tresiba flextouch u200 (insulin degludec) from unknown start date for "product used for unknown indication", tresiba penfill (insulin degludec) from unknown start date for "product used for unknown indication".It was also reported that, the products almost killed patient (almost died, collapsed).The outcome for the event "patient almost died (collapsed)(syncope)" was recovered.Since last submission, the case was updated with the following: -the event verbatim and coding of "patient almost died updated to "patient almost died (collapsed)(syncope)" and syncope.-annex e code, device narrative and eu/ca tab updated for novopen 5 -tresiba flex touch medwatch information tab updated -narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device (novopen 5) has been returned to novo nordisk for evaluation.Preliminary examination revealed that the cap, with the cartridge holder inside separated from the pen body.The detailed investigation of the device showed that it was working in accordance to specifications.It is therefore not possible to identify a clear root cause in relation to the functionality of the pen.Elderly age of the patient (73 years) is a significant confounding factor which could have contributed to syncope and poor glycaemic control.(b)(6) 2021: the suspected device (tresiba flextouch, batch no.Kzfr092 and kzfm803) has been returned to novo nordisk for evaluation.Since no faults were found on the returned device tresiba flextouch and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event.Elderly age of the patient (73 years) is a significant confounding factor which could have contributed to syncope and poor glycaemic control.Company comment: the event "syncope" is assessed as unlisted; diabetes mellitus inadequate control is assessed as listed according to the novo nordisk current ccds in tresiba flextouch.Relevant information on medical history, final diagnosis, action taken with tresiba flextouch are unavailable for complete causality assessment.Of note, product investigation, no irregularities related to the complaint were detected.Elderly age of the patient (73 years) is a significant confounding factor which could have contributed to syncope and poor glycaemic control.This single case report is not considered to change the current knowledge of the safety profile of tresiba flextouch."this report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo".

• Brand Name: NOVOPEN 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S,; bagsvaerd,, ; DA
• MDR Report Key: 12189175
• MDR Text Key: 262479919
• Report Number: 9681821-2021-00036
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Lot Number: KVGY043-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 07/19/2021; 07/29/2021
• Supplement Dates FDA Received: 07/30/2021; 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOVORAPID PENFILL (INSULIN ASPART).
• Patient Outcome(s): Other
• Patient Age: 73 YR