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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problems Fatigue (1849); Hyperglycemia (1905); Hypoglycemia (1912); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Coma [coma].Felt tiredness [fatigue].Ketoacidosis (diabetic patient) [diabetic ketoacidosis].The mechanical part and the piston rod didn't move normally and pen dose counter get stucked during injection (np4 and np3) [device mechanical issue].One np4 was broken at the cartridge [device breakage].Another novopen 4 not working normally [device issue].Hyperglycemia [hyperglycaemia].Used nn insulin with syringe [wrong technique in product usage process].Case description: this serious spontaneous case from egypt was reported by a consumer as "coma(coma)" with an unspecified onset date, "felt tiredness(tiredness)" with an unspecified onset date, "ketoacidosis (diabetic patient)(diabetic ketoacidosis)" with an unspecified onset date, "the mechanical part and the piston rod didn't move normally and pen dose counter get stucked during injection (np4 and np3)(device mechanical jam)" with an unspecified onset date, "one np4 was broken at the cartridge(device breakage)" with an unspecified onset date, "another novopen 4 not working normally(device issue)" with an unspecified onset date, "hyperglycemia(hyperglycemia)" with an unspecified onset date, "used nn insulin with syringe(wrong technique in product usage process)" with an unspecified onset date, and concerned a 14 years old female patient who was treated with actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency & route used - 10 iu, tid, subcutaneous) (therapy dates - ongoing) from unknown start date and ongoing for "diabetes", , novopen 3 (insulin delivery device) from unknown start date for "device therapy", , novopen 4 (insulin delivery device) from unknown start date for "device therapy", , novopen 4 (insulin delivery device) from unknown start date for "device therapy", patient's weight 32-35kg, height 70-65cm and body mass index not reported current condition: diabetes (since 10 years and type of diabetes not reported) historical condition: car accident, accumulate blood mass on her pancreas.Concomitant products included - lantus(insulin glargine).On an unknown date, the patient felt tiredness and expected that happened due to the technical problem in the novo pen and was hospitalized for 3 days 10 days ago.Patient used nn insulin in hospital with dose 10 u 3 times before meals by syringe on an unspecified date, 7 to 10 days ago, coma started and ended 7 days ago.On an unspecified date, 10-15 days ago, ketoacidosis started and ended 5-6 days ago.On an unspecified date, 15 days ago, hyperglycemia started and ongoing when pen training was offered with one of the novopen 4, it was noticed that the mechanical part and the piston rod didn't move normally after adjusting the dose counter to 60 u and pressing the dose twice) and the dose counter stopped at 1st time at 8u and the 2nd time at 25 u.With novopen 3 , the dose counter didn't move as it was stuck at 70u, he said that there was another novopen 4 that was not working normally and it was not available during the call.Batch numbers: actrapid penfill: mr7cl20.Novopen 3: unknown.Novopen 4: unknown.Novopen 4: unknown.Action taken to actrapid penfill was not reported.The outcome for the event "coma(coma)" was recovered.The outcome for the event "felt tiredness(tiredness)" was not reported.The outcome for the event "ketoacidosis (diabetic patient)(diabetic ketoacidosis)" was recovered.The outcome for the event "the mechanical part and the piston rod didn't move normally and pen dose counter get stucked during injection (np4 and np3)(device mechanical jam)" was not reported.The outcome for the event "one np4 was broken at the cartridge(device breakage)" was not reported.The outcome for the event "another novopen 4 not working normally(device issue)" was not reported.The outcome for the event "hyperglycemia(hyperglycemia)" was not recovered.The outcome for the event "used nn insulin with syringe(wrong technique in product usage process)" was not reported.References included: reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same patient and reporter.Preliminary manufacturer's comment: 05-jan-2023: the suspected device has not been returned to novo nordisk for evaluation.No conclusion is reached.Company comment: coma and fatigue are assessed as unlisted events; diabetic ketoacidosis and hyperglycaemia are assessed as listed events according to the novo nordisk current ccds in actrapid.Patient underlying long standing diabetes mellitus is a significant risk factor for the development of hyperglycaemia and diabetic ketoacidosis.Coma and fatigue could be clinical manifestation of diabetic ketoacidosis.We have not received the suspected faulty device for investigation.No conclusion is reached.This single case report is not considered to change the current knowledge of the safety profile of actrapid.

Event Description

Case description: investigational result: novopen 3 - batch unknown.The product was not returned for examination.Novopen 4 - batch dug0863.The product was not returned for examination.Actrapid penfill - batch mr7cl20.The product was not returned for examination.Since last submission the case was updated as follows: -investigational result updated.-imdrf codes updated.-narrative updated accordingly.03-mar-2023: the suspected device novopen 3 (batch number not valid) has not been returned to novo nordisk for evaluation.Valid batch number of the device unavailable despite repeated efforts to find the same.No batch trend analysis or reference sample analysis performed.With available limited information, it is not possible to identify the root cause in relation to functionality of novopen 3.However, incorrect handling of the product such as needle reusage, storing the device with needle attached, between injections and using dialling clicks to measure dosage can affect the functionality of devices.Additionally administering insulin without eating meals can leads to hypoglycaemia and its complications.03-mar-2023: the suspected device novopen 4 (batch number: dug0863) has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.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.However, incorrect handling of the product such as needle reusage, storing the device with needle attached, between injections and using dialling clicks to measure dosage can affect the functionality of devices.Additionally administering insulin without eating meals can leads to hypoglycaemia and its complications.H3 evaluation summary: novopen3: batch unknown.The product was not returned for examination.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycemic coma [hypoglycaemic coma] hyperglycemia coma [diabetic hyperglycaemic coma] pen technical issue -not deliver the specific dose [device delivery system issue] felt tiredness [fatigue] ketoacidosis (diabetic patient) [diabetic ketoacidosis] the mechanical part and the piston rod didn't move normally and pen dose counter get stucked during injection (np4 and np3) [device mechanical issue] one np4 was broken at the cartridge holder [device breakage] hyperglycemia [hyperglycaemia] the needle left attached in the pen [product storage error] used nn insulin with syringe [wrong technique in product usage process] case description: this serious spontaneous case from egypt was reported by a consumer as "hypoglycemic coma(hypoglycemic coma)" with an unspecified onset date, "hyperglycemia coma(coma hyperglycaemic)" beginning on 2021, "pen technical issue -not deliver the specific dose(inaccurate delivery by device)" with an unspecified onset date, "felt tiredness(tiredness)" with an unspecified onset date, "ketoacidosis (diabetic patient)(diabetic ketoacidosis)" with an unspecified onset date, "the mechanical part and the piston rod didn't move normally and pen dose counter get stucked during injection (np4 and np3)(device mechanical jam)" with an unspecified onset date, "one np4 was broken at the cartridge holder(device breakage)" with an unspecified onset date, "hyperglycemia(hyperglycemia)" with an unspecified onset date, "the needle left attached in the pen(device stored with needle attached)" with an unspecified onset date "used nn insulin with syringe(wrong technique in product usage process)" with an unspecified onset date and concerned a 14 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "device therapy", , novopen 4 (insulin delivery device) from unknown start date for "device therapy", , actrapid penfill (insulin human) from unknown start date and ongoing for "diabetes", current condition: diabetes (since 10 years and type of diabetes not reported) historical condition: car accident, accumulate blood mass on her pancreas, hyperglycemia (from 10 years ago).Started actrapid 10 years ago.On an unspecified date, the patient experienced hypoglycemia coma and on an unspecified date in 2021, the patient had hyperglycemic coma 4-5 times and between each coma was around 4-5 months.Duration of hospitalization was 3-7 days.The other causes provided for the cause of coma was due to taking insulin without eating her meal, the pen technical issue -not deliver the specific dose.It was also reported that the needle was left atatched with the pen.During pen training with one of the novopen 4, it was noticed that the mechanical part and the piston rod didn't move normally after adjusting the dose counter to 60 u and pressing the dose twice) and the dose counter stopped at 1st time at 8u and the 2nd time at 25 u.In novopen 3 , the dose counter didn't move as it was stuck at 70u.It was also reported that novopen 4 was broken at the cartridge holder and get lost and only the mechanical part was available with him.The treatment for hyperglycemia was a correction dose as her correction factor was 1u decreases 30mg/dl when her blood glucose level was above 200mg/dl batch numbers: novopen 3: requested novopen 4: dug0863 actrapid penfill: mr7cl20 the outcome for the event "hypoglycemic coma(hypoglycemic coma)" was recovered.The outcome for the event "hyperglycemia coma(coma hyperglycaemic)" was recovered.The outcome for the event "pen technical issue -not deliver the specific dose(inaccurate delivery by device)" was not reported.The outcome for the event "felt tiredness(tiredness)" was not reported.The outcome for the event "ketoacidosis (diabetic patient)(diabetic ketoacidosis)" was recovered.The outcome for the event "the mechanical part and the piston rod didn't move normally and pen dose counter get stucked during injection (np4 and np3)(device mechanical jam)" was not reported.The outcome for the event "one np4 was broken at the cartridge holder(device breakage)" was not reported.The outcome for the event "hyperglycemia(hyperglycemia)" was not recovered.The outcome for the event "the needle left attached in the pen(device stored with needle attached)" was not reported.The outcome for the event "the nn insulin with syringe(wrong technique in product usage process)" was not reported.Since last submission the case was updated as follows: -additional serious event of "hypoglycemia coma", "hyperglycemia coma", "pen technical issue -not deliver the specific dose" was added and nonserious event of "the needle left attached in the pen" was added.-event coma removed.-suspect novopen 4 removed as incorrectly reported previously.-event not working normally removed and subsumed under device mechanical issue as no other novopen 4 was there -reporter causality updated for tiredness, diabetic ketoacidosis and hyperglycemia.-medical history of hyperglycemia added.-treatment details updated.-reporters comment updated.-narrative updated accordingly.//knlb -batch number updated for novopen 4 -expiry and manufacturing dates updated -narrative updated accordingly.Preliminary manufacturer's comment: 19-jan-2023: the suspected device novopen has not been returned to novo nordisk for evaluation.No conclusion is reached.Incorrect handling of the product such as needle reusage, storing the device with needle attached, between injections and using dialling clicks to measure dosage can affect the functionality of devices.Additionally administering insulin without eating meals can leads to hypoglycaemia and its complications.Company comment: hypoglycaemic coma, hyperglycaemic coma and diabetic ketoacidosis are assessed as listed; fatigue is assessed as unlisted event according to the novo nordisk current ccds in actrapid.Patient underlying long standing diabetes mellitus is a significant risk factor for the development of hyperglycaemia and diabetic ketoacidosis.Hyperglycaemic coma and fatigue could be clinical manifestation of diabetic ketoacidosis.We have not received the suspected faulty device for investigation.Incorrect handling of the product such as needle reusage, storing the device with needle attached, between injections and using dialling clicks to measure dosage can affect the functionality of devices.Additionally administering insulin without eating meals can leads to hypoglycaemia and its complications.This single case report is not considered to change the current knowledge of the safety profile of actrapid.Reporter comment: -other causes for coma: during hypoglycemia coma was due to taking insulin without eating her meal, and during hyperglycemia coma was due to the pen technical issue -not deliver the specific dose- from 8 years ago.

• Brand Name: NOVOPEN 3
• 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: 16132060
• MDR Text Key: 307017932
• Report Number: 9681821-2023-00004
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: 19-938
• 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,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• 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
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: LANTUS (INSULIN GLARGINE)
• Patient Outcome(s): Other; Life Threatening; Hospitalization
• Patient Age: 14 YR
• Patient Sex: Female