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.

• 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