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

Model Number N/A

Device Problems Inaccurate Delivery (2339); Mechanical Jam (2983)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycaemia [hypoglycaemia].Pen jammed (the piston rod was not moving forward properly) [device mechanical issue].Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "hypoglycaemia(hypoglycaemia)" with an unspecified onset date, "pen jammed (the piston rod was not moving forward properly)(device mechanical jam)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus".Patient height, weight and body mass index was not reported.Current condition: type 1 diabetes mellitus (duration was not reported).Concomitant products included - novorapid(insulin aspart) solution for injection, 100 iu/ml on an unspecified date, the patient reported that the pen was jammed (piston rod was not moving forward properly) and therefore not transporting enough insulin.Therefore, the patient estimated how much novorapid had to inject and injected himself and then experienced hypoglycaemia with it for which the emergency doctor had to be called.Batch number has been requested.The outcome for the event "hypoglycaemia(hypoglycaemia)" was not reported.The outcome for the event "pen jammed (the piston rod was not moving forward properly)(device mechanical jam)" was not reported.

Event Description

Case description: no further information was available.Investigation results: novopen 4- batch unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Final manufacturer's comment: 15-nov-2021: the suspected device (novopen 4) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available, no batch trend analysis or reference sample analysis 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 unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.

• 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: 12525084
• MDR Text Key: 273089698
• Report Number: 9681821-2021-00059
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• 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: NOVORAPID (INSULIN ASPART).; NOVORAPID (INSULIN ASPART)
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male