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

Model Number N/A

Device Problems Defective Device (2588); Improper Flow or Infusion (2954)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas); hyperglycemia [hyperglycaemia]; technical issue with pen [device issue]; novopen 4 didn't inject normally [device delivery system issue].Case description: this serious spontaneous case from egypt was reported by a consumer as "hyperglycemia(hyperglycemia)" with an unspecified onset date, "technical issue with pen(device issue)" with an unspecified onset date, "novopen 4 didn't inject normally(device delivery system issue)" with an unspecified onset date, and concerned a 28 years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy," actrapid penfill (insulin human) (dose, frequency & route used- 81 iu, qd, subcutaneous) from unknown start date and ongoing for "type 1 diabetes." patient's height: 157 cm.Patient's weight: 54 kg.Patient's bmi: 21.90758250.Dosage regimens: novopen 4: actrapid penfill: current condition: type 1 diabetes (since 2005).Concomitant products included - lantus (insulin glargine).It was reported that actrapid penfill was started 16 years ago.On an unspecified date, the patient suffered from hyperglycemia due to a technical issue with the novopen 4 (not specified).Hyperglycemia event started from 16 years, causality is unlikely with actrapid and probable with novopen 4.It was mentioned that pen training was offered and during it, the mechanical part and the piston rod moved normally after adjusting the dose counter on 60 u and pressing the dose button and after moving it out by her hand then after adding a new penfill and add newneedle the pen didn't inject normally (dates unknown), so the batch no.Was taken.Patient's, hba1c was 8.1% from a month ago (dates unknown), her random blood glucose was 430-495mg/dl in the morning and 398mg/dl at night yesterday (date unspecified).Batch numbers of novopen 4 was requested.Actrapid penfill: mr7cl80.Action taken to novopen 4 was reported as other.Action taken to actrapid penfill was reported as no change.The outcome for the event "hyperglycemia(hyperglycemia)" was not yet recovered.The outcome for the event "technical issue with pen(device issue)" was not yet recovered.The outcome for the event "novopen 4 didn't inject normally(device delivery system issue)" was not yet recovered.References included: reference type: e2b linked report; reference id#: (b)(4); reference notes: same patient.Reporter comment: batch number novopen 4: bug1299 (non valid).

Event Description

Case description: investigation result: novopen® 4, batch number: bug1299 (non valid).The product was not returned for examination.Actrapid® penfill® 3 ml 100iu/ml, batch number: mr7cl80.The product was not returned for examination.Since last submission, this case has been updated with the following investigation result updated.Imdrf codes added.Narrative updated accordingly.References included: reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same patient.Final manufacturer's comment: 14-mar-2023: the suspected device novopen 4 has not been returned to novo nordisk for investigation.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.Patient's underlying medical condition of type 1 diabetes mellitus is a confounding factor for the development of hyperglycaemia.H3 continued: evaluation summary: novopen® 4, batch number: bug1299 (non valid).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: 16319685
• MDR Text Key: 309019516
• Report Number: 9681821-2023-00023
• 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: 01/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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: 03/10/2023
• 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: LANTUS (INSULIN GLARGINE) ONGOING
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 54 KG