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

Model Number N/A

Device Problems Crack (1135); Inaccurate Delivery (2339); Device Handling Problem (3265)

Patient Problem Hyperglycemia (1905)

Event Date 10/01/2023

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose unstable with fasting blood glucose of below 6 mmol/l and postprandial blood glucose 7-10 mmol/l [blood glucose increased].The pen holder of the replaced novopen 4 was cracked [device breakage] patient thought that injection dose by novopen 4 was inaccurate [device delivery system issue].Severe wear and tear after prolonged use of novopen 3 [device physical property issue].Blood glucose increased [blood glucose increased] blood glucose increased [blood glucose increased] hypoglycemia [hypoglycaemia].Fasting blood glucose was 10 mmol/l and postprandial blood glucose was 15 mmol/l [blood glucose increased] insulin resistance [insulin resistance].The pen was stored with the needle on it, and the needle was discarded after use at home [product storage error].Case description: this serious spontaneous case from china was reported by a consumer as "blood glucose unstable with fasting blood glucose of below 6 mmol/l and postprandial blood glucose 7-10 mmol/l(blood glucose increased)" beginning on (b)(6) 2023, "the pen holder of the replaced novopen 4 was cracked(device cracked)" with an unspecified onset date, "patient thought that injection dose by novopen 4 was inaccurate(inaccurate delivery by device)" with an unspecified onset date, "severe wear and tear after prolonged use of novopen 3(device damage)" with an unspecified onset date, "blood glucose increased(blood glucose increased)" beginning on 2023, "blood glucose increased(blood glucose increased)" beginning on aug-2023, "hypoglycemia(hypoglycemia)" with an unspecified onset date, "fasting blood glucose was 10 mmol/l and postprandial blood glucose was 15 mmol/l(blood glucose increased)" beginning on (b)(6) 2023, "insulin resistance(insulin resistance)" with an unspecified onset date, "the pen was stored with the needle on it, and the needle was discarded after use at home(device stored with needle attached)" with an unspecified onset date and concerned a 58 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date for "type 2 diabetes mellitus", novopen 3 (insulin delivery device) from unknown start date for "device therapy", novorapid penfill (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - 15 iu, tid) (therapy dates - ongoing) from unknown start date and ongoing for "type 2 diabetes mellitus", tresiba (insulin degludec 100 iu/ml) solution for injection, 100 iu/ml (dose, frequency & route used - 30 iu, qd) from unknown start date and ongoing for "type 2 diabetes mellitus", tresiba penfill (insulin degludec 100 iu/ml) solution for injection, 100 iu/ml (dose, frequency & route used - 30 iu, qd) from unknown start date and ongoing for "type 2 diabetes mellitus".Patient's height: 180 cm; patient's weight: 82 kg; patient's body mass index (bmi): 25.308642.Current condition: type 2 diabetes mellitus (for 30 years); historical condition: diabetic ketosis; historical drug: novolin 30r and ursulin (non-codable); procedure: hospitalisation.On an unknown date, hypoglycemia occurred (reported as before (b)(6) 2023) (about 3-5 times a week, usually due to skipping meals for high blood glucose, or excessive exercise) with fasting blood glucose (blood glucose) 3 mmol/l it was reported that in and around (b)(6) 2023, patient felt the blood glucose was unstable with fasting blood glucose(blood glucose) 10 mmol/l and patient's post prandial blood glucose(blood glucose) was 15 to 20mmol/l.On (b)(6) 2023, the patient's fasting blood glucose(blood glucose) was 10 mmol/l and patient's post prandial blood glucose(blood glucose) was 15 to 20mmol/l.On an unknown date, 3 pieces of novopen (2 pieces of novopen 3 and 1 piece of novopen 4) were replaced.It was confirmed that there were no issues with 1 piece of novopen 4, and it was not replaced,the patient felt that the pens had similar problems before, and after replacing the novopen 4, and also confirmed that the pen holder of the replaced novopen 4 was cracked.Patient said there was a resistance at the beginning of injection, and the resistance was not felt later.The patient was worried if the insulin injection dose was inaccurate.On an unknown date in (b)(6) 2023, the patient was hospitalized during the national day period, for about 5 days to adjust blood glucose, since the patient experienced blood glucose unstable with fasting blood glucose (blood glucose) was below 6 mmol/l and postprandial blood glucose (blood glucose) was 7-10 mmol/l due to the technical complaints experienced with novopen 4.The patient will seek medical attention later and ask the doctor again.On an unknown date,the pen was stored with the needle on it, and the needle was discarded after use at home.After discharge, around (b)(6) 2023, patient had unstable blood glucose with fasting blood glucose (blood glucose was also around 10 mmol/l and postprandial blood glucose (blood glucose) was around 15 mmol/l.And sought medical attention, but the patient did not disclose the exact reason and believed that his self-control was poor.It was reported that the patient will go to the local office for inspection and replacement of novopen.Novorapid and tresiba were not discontinued, and the dosage was not changed.The patient believed that there were no unexpected occurrences before the adverse event, and that the abnormality of the pen holder was one of the factors for subsequent adverse events.There were also other factors, such as diet and exercise.After installing the pen holder, flow test will be conducted.Recently, there was an increase in diet (the patient sometimes went out and ate too much sugar), and the amount of activity was sometimes not enough.The needle was prescribed by the hospital, the brand was unknown, and it was 32g 4mm needle.The patient reused needles when going out, but ensured single use of needles at home.During injection, the patient checked the dose window to confirm that the dose had been injected, but at the same time, the patient also listened to the dialing clicks.The patient believed that the dialing clicks matches the dose.On an unknown date, patient confirmed that currently novorapid was used with novopen 4 for injection, while tresiba was used with novopen 3 for injection, which may also use drug and device interchangeably.The patient considered that severe wear and tear after prolonged use of novopen 3, as well as cracking of the pen holder of novopen 4, may be the reasons for unstable blood sugar levels.The patient thought that the blood sugar unable to be fully controlled for 24 hours after the injection of tresiba, and thought that fasting blood sugar increased after 20 hours.So now, from taking 30u once a day changed to 15u twice a day.The fasting blood sugar still 10mmol/l every morning, and patient believed that exceeding 9.5mmol/l is hyperglycemia.The patient thought that may have insulin resistance and unwilling to see doctor because the doctor just adviced to adjust injection dosage based on the patient's blood sugar level.The patient initially used novopen 3 and novolin 30r.Due to poor blood sugar control, the patient used ursulin for a short period of time, but later changed to novopen 3 and novopen 4, both of which had been injected with novorapid.During the covid-19, due to the inability to purchase and the use of other china domestic insulin (with unclear names and date) for one month, the injection felt different and blood sugar control was not good, so switched back to novorapid and tresiba.Batch numbers: novopen 4: yug0605; novopen 4: bug1653 ; novopen 3: asku; novorapid penfill: asku ; tresiba: asku; tresiba penfill: asku.Action taken to novopen 4 was not reported.Action taken to novorapid penfill was reported as no change.Action taken to tresiba was reported as no change.Action taken to tresiba penfill was reported as no change.On (b)(6) 2023 the outcome for the event "blood glucose unstable with fasting blood glucose of below 6 mmol/l and postprandial blood glucose 7-10 mmol/l(blood glucose increased)" was recovered.The outcome for the event "the pen holder of the replaced novopen 4 was cracked(device cracked)" was not recovered.The outcome for the event "patient thought that injection dose by novopen 4 was inaccurate(inaccurate delivery by device)" was not reported.The outcome for the event "severe wear and tear after prolonged use of novopen 3(device damage)" was not reported.The outcome for the event "blood glucose increased(blood glucose increased)" was recovered.The outcome for the event "blood glucose increased(blood glucose increased)" was recovered.The outcome for the event "hypoglycemia(hypoglycemia)" was recovered.The outcome for the event "fasting blood glucose was 10 mmol/l and postprandial blood glucose was 15 mmol/l(blood glucose increased)" was not recovered.The outcome for the event "insulin resistance(insulin resistance)" was not recovered.The outcome for the event "the pen was stored with the needle on it, and the needle was discarded after use at home(device stored with needle attached)" was not reported since last submission the case has been updated with the following: product tab updated (novopen 3 added and dosage regimen of novorapid) new event added(insulin resistance and device damage) narrative updated accordingly.References included: reference type: e2b company number; reference id#: (b)(4).Reference notes: reference type: e2b linked report; reference id#:(b)(4); reference notes: same patient.Block c - additional dosage regimens.Suspect product 2.Dose, frequency & route used 3.Therapy dates (if unknown, give duration) 6.Lot # 7.Exp.Date #2 tresiba penfill regimen #2 15 iu, bid ongoing.#3 tresiba regimen #2 15 iu, bid ongoing.

Event Description

Case description: investigation results: name: novopen 4, batch number: bug1653.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.Name: novorapid penfill, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: tresiba flextouch u100, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: tresiba penfill 100u, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Name: novopen 3, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Final manufacturer's comment: 28-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.Long standing history of type 2 diabetes mellitus for 20 years is a significant confounding factor for the development of hyperglycaemia.H3 continued: evaluation summary: name: novopen 4, batch number: bug1653.The number of complaints on the batch was evaluated and, when applicable, relevant actions were taken.The product was not returned for examination.

• 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: 18185388
• MDR Text Key: 328705109
• Report Number: 9681821-2023-00158
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• 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: 185490
• Device Lot Number: BUG1653
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 82 KG