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

Model Number N/A

Device Problems Fracture (1260); Defective Device (2588)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Event Description

Np3 issue [device malfunction].Uncontrolled diabetes (hyper) due to her novopen 3 issue [hyperglycaemia].Uncontrolled diabetes (hypo, below 20 mg/dl) due to her novopen 3 issue [hypoglycaemia].Penfill is broken [product physical issue].The insulin leak [product leakage].Diluted type of mixtard [liquid product physical issue].She was using first diluted type of mixtard [poor quality product administered].Case description: this serious spontaneous case from egypt was reported by a consumer as "np3 issue(device malfunction)" with an unspecified onset date, "uncontrolled diabetes (hyper) due to her novopen 3 issue(hyperglycemia)" with an unspecified onset date, "uncontrolled diabetes (hypo, below 20 mg/dl) due to her novopen 3 issue(hypoglycemia)" with an unspecified onset date, "penfill is broken(cracked product)" with an unspecified onset date, "the insulin leak(product leakage)" with an unspecified onset date, "diluted type of mixtard(abnormal liquid product viscosity)" with an unspecified onset date, "she was using first diluted type of mixtard(poor quality product administered)" with an unspecified onset date, and concerned a 61 years old female patient who was treated with novopen 3 (insulin delivery device) from unknown start date for "device therapy", , mixtard 30 hm penfill (insulin human) (dose, frequency & route used-53 iu, qd (38 u am -15 u pm), subcutaneous) from unknown start date and ongoing for "type 1 diabetes mellitus".Patient's height: 163 cm, patient's weight: 79 kg, patient's bmi: 29.73390040.Current condition: type 1 diabetes mellitus (about 50 years), hypertension (3-4 years, was informed that it is associated to diabetes (as per her hcp's words), cardiac insufficiency (3 yaers (diabetes complication as per her hcp's words), hypothyroidism (from 8-10 years), renal insufficiency (3-4 yaers diabetes complication as per her hcp's words), gastritis, cardiac problems, hypercholesterolemia, kidney problem, thrombosis, diuresis, cataract (from 18-19 years).Procedure: unplugging surgeries (from 18-19 years), hospitalization (hospitalization for both surgeries except that she was discharged in the same day).Concomitant products included - nexium [esomeprazole sodium](esomeprazole sodium 40mg ongoing), eltroxin(levothyroxine sodium), vastarel mr(trimetazidine hydrochloride), ator(atorvastatin calcium), sodium bicarbonate, forxiga(dapagliflozin propanediol monohydrate 5 mg ongoing), aggrex(acetylsalicylic acid), plendil(felodipine), adancor(nicorandil), carvid(carvedilol), examide(torasemide).On an unknown date, patient's novopen 3 had issue (not specified) and mixtard 30 penfill was broken, and insulin leaked.So, the patient did not take her dose and suffered from hyperglycaemia.On an unknown date hyperglycaemia disappeared.It was also reported that the day before yesterday (date not specified), she suffered from hyperglycemia the whole day till night although she was not eating, at night she took 4 iu.It was reported that yesterday (date not specified) the patient took her dose and suffered from hypoglycemia, dizziness although she did not perform any extra effort.It was also reported that from 3 months the patient suffered from hypoglycemia several times.Patient's relatives called the ambulance for her and her rbg levels was below 20 mg/dl.It was mentioned that, patient was using first diluted type of mixtard, the patient prescribed to use the condensed one from hospital.The pharmacist injected with the condensed one, so the patient felt dizzy, and mentioned that felt dizzy for whole day.Patient was feeling better when when patient eats only.It was also reported that on an unknown date, patient's hba1c was 7 although it is normally from 6 to 6.5 (units not reported).Batch numbers: novopen 3: unknown.Mixtard 30 hm penfill: mr7cl55.Action taken to mixtard 30 hm penfill was not reported.The outcome for the event "np3 issue(device malfunction)" was not reported.The outcome for the event "uncontrolled diabetes (hyper) due to her novopen 3 issue(hyperglycemia)" was not yet recovered.The outcome for the event "uncontrolled diabetes (hypo, below 20 mg/dl) due to her novopen 3 issue(hypoglycemia)" was not yet recovered.The outcome for the event "penfill is broken(cracked product)" was not reported.The outcome for the event "the insulin leak(product leakage)" was not reported.The outcome for the event "diluted type of mixtard(abnormal liquid product viscosity)" was not reported.The outcome for the event "she was using first diluted type of mixtard(poor quality product administered)" was not reported.References included: reference type: e2b linked report, reference id#: (b)(4), reference notes: same patient, reference type: e2b linked report, reference id#: (b)(4), reference notes: same patient, reference type: e2b linked report, reference id#: (b)(4), reference notes: same reporter, reference type: e2b company number, reference id#: (b)(4), reference notes.

Event Description

Case description: investigation result: name:novopen 3.The product was not returned for examination.Name:mixtard 30 hm penfill.Batch no:mr7cl55.The product was not returned for examination.Final manufacturer's comment: 03-mar-2023: the suspected device novopen 3 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.Events are listed.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30 hm penfill.H3 continued: evaluation summary: name:novopen 3.The product was not returned for examination.

• 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: 16202023
• MDR Text Key: 307670139
• Report Number: 9681821-2023-00012
• 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
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• 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: ADANCOR (NICORANDIL) ONGOING; AGGREX (ACETYLSALICYLIC ACID) ONGOING; ATOR (ATORVASTATIN CALCIUM) , 40 MG ONGOING; CARVID (CARVEDILOL) , 25 MG ONGOING; ELTROXIN (LEVOTHYROXINE SODIUM) ONGOING; EXAMIDE (TORASEMIDE) , 10 MG ONGOING; FORXIGA (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE); NEXIUM [ESOMEPRAZOLE SODIUM] (ESOMEPRAZOLE SODIUM); PLENDIL (FELODIPINE) , 10 MG ONGOING; SODIUM BICARBONATE (SODIUM BICARBONATE) ONGOING; VASTAREL MR (TRIMETAZIDINE HYDROCHLORIDE) ONGOING
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 79 KG