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

Model Number N/A

Device Problem Product Quality Problem (1506)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycaemia unconsiousness [hypoglycaemic unconsciousness] pen does not memory function the patient sometimes does not remember, sometimes she takes it twice [extra dose administered] body weight gain [weight increased] case description: this serious spontaneous case from poland was reported by a consumer as "hypoglycaemia unconsiousness(hypoglycemic unconsciousness)" with an unspecified onset date, "pen does not memory function the patient sometimes does not remember, sometimes she takes it twice(extra dose administered)" with an unspecified onset date, "body weight gain(weight gain)" with an unspecified onset date, and concerned a 24 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", tresiba penfill 100 u/ml (insulin degludec) (dose, frequency & route used- 25 iu, qd, subcutaneous) from sep-2022 and ongoing for "type 1 diabetes mellitus", a non-novo nordisk suspect product insulin aspart (insulin aspart) (dose, frequency & route used- 18 iu, qd, subcutaneous) from sep-2022 and ongoing for "type 1 diabetes mellitus", patient's height: 174 cm; patient's weight: 83 kg; patient's bmi: 27.41445370.Dosage regimens: novopen 4: tresiba penfill 100 u/ml: ??-sep-2022 to not reported (dosage regimen ongoing); ??-sep-2022 to not reported (dosage regimen ongoing); current condition: type 1 diabetes mellitus (diagnosed 12 years ago), seborrheic dermatitis; historical condition: cataracts of both eyes; historical drug: novorapid, insulatard; procedure: cataracts operated.Concomitant products included - rybelsus 14 mg(semaglutide) tablet, 14 mg 01/--/2023 to ongoing it was reported that, patient has been using novopen 4 injector.As the pen does not memory function the patient sometimes does not remember whether a dose of insulin has been taken and sometimes patient takes it twice, which resulted in hypoglycemia and unconsciousness with blood glucose (blood glucose) 45 mg/dl (usual blood glucose level was 55-68 mg/dl) and that has led to hospitalization twice (dates were not specified) on unspecified date in jan-2023, the patient weighed (weight) 100 kg through excess insulin use, and now the patient has managed to lose 15 kg.It was reported that patient had not recently switched from another product (within last 3 months) batch number of novopen 4: not reported; tresiba penfill 100 u/ml: not reported; action taken to novopen 4 was reported as unknown.Action taken to tresiba penfill 100 u/ml was reported as no change.Action taken to insulin aspart was reported as no change.The outcome for the event "hypoglycaemia unconsiousness(hypoglycemic unconsciousness)" was recovered.The outcome for the event "pen does not memory function the patient sometimes does not remember, sometimes she takes it twice(extra dose administered)" was unknown.The outcome for the event "body weight gain(weight gain)" was recovered.No further information available.References included: reference type: e2b linked report reference id#: (b)(4).Reference notes: same patient.

Event Description

Case description: investigational result.Novopen® 4 batch number :unknown.No investigation was possible, because neither sample nor batch number was available.Tresiba® penfill® batch number:unknown.No investigation was possible, because neither sample nor batch number was available.Since last submission, this case has been updated with the following investigation result added.Imdrf code added.Relevant fields updated in eu/ca tab.Narrative updated accordingly.Final manufacturer's comment: (b)(6) 2023: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.Novopen 4 does not have memory function.Relevant information on specific complaints on technical issues or device malfunction, product use issue is unavailable.Since patient administered extra dose, experienced hypoglycaemic unconsciousness.Batch number of devices is not available despite repeated efforts find the same.Batch trend analysis or reference sample analysis was not performed.No 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.H3 continued: evaluation summary.Novopen® 4 batch number :unknown.No investigation was possible, because neither sample nor batch number was available.

• 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: 17123644
• MDR Text Key: 317148271
• Report Number: 9681821-2023-00083
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: PL
• 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: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2023
• 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: RYBELSUS 14 MG (SEMAGLUTIDE) TABLET, 14 MG
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 83 KG