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

Model Number N/A

Device Problems Failure to Deliver (2338); No Flow (2991)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Novopen 4 did not inject insulin [device failure].Hyperglycaemia [hyperglycaemia].Case description: this serious spontaneous case from egypt was reported by a consumer as "novopen 4 did not inject insulin(device failure)" with an unspecified onset date, "hyperglycaemia(hyperglycaemia)" with an unspecified onset date, and concerned a 67 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", mixtard 30 hm penfill (insulin human, insulin isophane) (dose, frequency & route used- 40 iu, qd (30 u at morning and 10 u at night), subcutaneous) from unknown start date and ongoing for "diabetes mellitus".Patient's height: 125 cm.Patient's weight: 90 kg.Patient's bmi: 57.60.Dosage regimens: novopen 4: mixtard 30 hm penfill: current condition: diabetes mellitus (since 50 years older, type not reported), hypertension, colon, low vision, headache, diabetes complications, nerves.Historical condition: virus c.Procedure: abdominal surgery.Concomitant products included - milga(benfotiamine, cyanocobalamin, pyridoxine hydrochloride), concor 5 plus(bisoprolol fumarate, hydrochlorothiazide) tablet ongoing, antodine [famotidine](famotidine) ongoing, efamol(oenothera biennis oil) ongoing patient started to use mixtard penfill from 15 years ago.On an unknown date patient's blood glucose (blood glucose) was controlled with 160 mg/dl under mixtard.On an unknown date patient's novopen 4 did not inject insulin and patient experienced hyperglycemia as blood glucose (blood glucose) level reached to 500 mg/dl.So patient took her insulin dose by normal syringe.It was reported that the pen issue solved as per successful trouble shooting batch numbers: novopen 4 was requested, mixtard 30 hm penfill: m27gw28.Action taken to novopen 4 was not reported.Action taken to mixtard 30 hm penfill was reported as no change.The outcome for the event "novopen 4 did not inject insulin(device failure)" was not reported.The outcome for the event "hyperglycaemia(hyperglycaemia)" was not reported.

Event Description

Case description: investigational result: novopen 4, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Mixtard 30 penfill 3 ml 100iu/ml, batch number: m27gw28.No conclusion can be made without the sample or a valid batch number.The reported batch number is 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.Final manufacturer's comment: 30-jan-2024: 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.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.Elderly age and underlying long standing diabetes mellitus are significant confounding factors for the development of hyperglycaemia.H3 continued: evaluation summary: name: 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: 18393860
• MDR Text Key: 331323618
• Report Number: 9681821-2023-00178
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• 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: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: ANTODINE [FAMOTIDINE] (FAMOTIDINE) ONGOING; CONCOR 5 PLUS (BISOPROLOL FUMARATE, HYDROCHLOROTHI); EFAMOL (OENOTHERA BIENNIS OIL) ONGOING; MILGA TABLET ONGOING
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 90 KG