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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Defective Device (2588)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912); Damage to Ligament(s) (1952); Joint Dislocation (2374); Coma (2417); Muscle/Tendon Damage (4532)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) ligament tear at shoulder [ligament rupture], shoulder dislocation [joint dislocation], inflamed tendons [tendon injury], hypoglycemic coma and falling down [hypoglycaemic coma], problem with the device used [device issue], hyperglycemia [hyperglycaemia], the needle left attached to the pen in between injections [product storage error].Case description: this serious spontaneous case from egypt was reported by a consumer as "ligament tear at shoulder(ligament tear)" with an unspecified onset date, "shoulder dislocation(shoulder dislocation)" with an unspecified onset date, "inflamed tendons(tendon injury)" with an unspecified onset date, "hypoglycemic coma and falling down(hypoglycemic coma)" with an unspecified onset date, "problem with the device used(device issue)" with an unspecified onset date, "hyperglycemia(hyperglycemia)" with an unspecified onset date, "the needle left attached to the pen in between injections(device stored with needle attached)" with an unspecified onset date, and concerned a male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", , novorapid penfill (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - 60-70 iu/day) from unknown start date for "type 1 diabetes mellitus", , novorapid flexpen (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - unk) from unknown start date for "type 1 diabetes mellitus", patient's height: 179 cm.Patient's weight: 75 kg.Patient's bmi: 23.40750910.Current condition: type 1 diabetes mellitus.Treatment included - alphintern(chymotrypsin, trypsin), alpha plus(alfacalcidol).On an unknown date 10 years ago patient started using novorapid penfill and novorapid flexpen and sometimes switched from use flexpen to use penfill of novorapid.On an unknown date, one year ago the patient had problem with novopen used and due to this experienced hypoglycemic coma, falling down due to which the patient had shoulder dislocation, for which only had diet meal or sugar source and it also led to ligament tear at shoulder.Patient took just sugar source as a treatment for this hypoglycemic coma.It was reported that the force needed to inject feel different from normal (lower/easier).The patient also mentioned that he was an athletic and usually injured himself and he could not confirm the causality for this event due to the novorapid or his careless added he suffered from other injuries as ligament tears and inflamed tendons through the last year.On an unknown date, patient had hyperglycemia (it was reported that this event hasn't led to hospitalization).It was reported that the patient already used needle in general reuses the needles, left the needle attached to the pen in between injections the patient didn't use insulin suspension (cloudy insulin) , didn't use the dialling clicks to estimate the dose of the product, has been trained by a health care professional in the use of thenovopen.There was a recent changed in patient's diet or exercise level.Batch numbers: novopen 4: evg2785.Novorapid penfill: nrkv58.Novorapid flexpen: requested.Action taken to novorapid penfill was not reported.Action taken to novorapid flexpen was not reported.The outcome for the event "ligament tear at shoulder(ligament tear)" was not yet recovered.The outcome for the event "shoulder dislocation(shoulder dislocation)" was not yet recovered.The outcome for the event "inflamed tendons(tendon injury)" was not yet recovered.The outcome for the event "hypoglycemic coma and falling down(hypoglycemic coma)" was unknown.The outcome for the event "problem with the device used(device issue)" was not reported.The outcome for the event "hyperglycemia(hyperglycemia)" was not reported.The outcome for the event "the needle left attached to the pen in between injections(device stored with needle attached)" was not reported.Since last submission, the case has been updated with the following: -suspect (novopen 4) was updated.-relevant device fields updated.-eu/ca tab and device addendum tab updated; imdrf codes added.- events device delivery system issue, hyperglycemia, device stored with needle attached was updated.- narrative was updated accordingly.References included: reference type: e2b linked report.Reference id#: eg-novoprod-1122251.Reference notes: same patient case.Reference type: e2b company number.Reference id#: eg-novoprod-1123652.Company comment: ligament tear, joint dislocation and tendon injury are assessed as unlisted events; hypoglycemic coma is assessed as listed event according to novonordisk current reference safety information on novorapid penfill and novorapid flexpen the information regarding event and therapy dates, final diagnosis, circumstances leading to the reported event, chronology of events, complete medical history are unavailable which limits the medical assessment of the case.This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill and novorapid flexpen reporter comment: the needle attached to the pen in a 180 degree angle (straight on) the insulin in use preserved at room temperature 20-25 degrees celsius · the patient haven't changed from another novopen to the current novopen.

Event Description

Case description: investigational result: name: novopen 4, batch number: evg2785.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Name: novorapid penfill 3 ml 100iu/ml, batch number: nrkv58.- no conclusion can be made without the sample or a valid batch number.- the reported batch number was not valid.- the number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.-the product was not returned for examination.- if possible, please forward the reported product(s) for further investigations.Name: novorapid flexpen batch number: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission, the case has been updated with the following: - inv results were updated.- imdrf codes were updated.- narrative was updated accordingly.Final manufacturer's comment: on 26-dec-2023: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.Batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.No other confounding factors identified.With the available limited information regarding the handling of the suspected device, it is not possible to identify a clear root cause in relation to functionality of novopen 4.Patient's underlying medical condition of type 1 diabetes is a significant risk factor for the development of hypoglycaemic coma and hyperglycaemia.As patient is an athlete, ligamental tear, tendon injury and joint dislocation could be attributed to self injury while athletic activity, not related to novorapid insulin.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 18133027
• MDR Text Key: 328111089
• Report Number: 9681821-2023-00151
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: EVG2785
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 75 KG