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

Model Number N/A

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 06/09/2018

Event Type  Injury  

Event Description

Severe hypoglycaemia [hypoglycaemia].Novopen 4 over delivering the insulin dose that was delivered with the priming dose [incorrect dose administered by device].Case description: this serious spontaneous case from (b)(6) was reported by a diabetes nurse specialist as "severe hypoglycaemia" beginning on (b)(6) 2018, "novopen 4 over delivering the insulin dose that was delivered with the priming dose" beginning on (b)(6) 2018, and concerned a 9 years old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus".Patient's height: 146 cm; patient's weight: (b)(6); patient's bmi: 18.296.Medical history included type 1 diabetes mellitus (recent diagnosis entering honeymoon phase).Concommitant medication included - lantus junior star pen (non-codable), insulin.On an unknown date in 2018, the mother of the patient changed the cartridge into a novopen 4 and primed the pen and was surprised at the force of insulin that was delivered with the priming dose.The mother then dialled up the dose and administered.On (b)(6) 2018, the patient experienced severe hypoglycaemia requiring admission to hospital in an ambulance.It was presumed that, the hypoglycaemia was due to the pen over delivering an insulin dose.The patient was discharged in (b)(6) 2018.Information on batch number was not provided.Action taken to novopen 4 was product discontinued.On (b)(6) 2018 the outcome for the event "severe hypoglycaemia" was recovered with sequelae.The outcome for the event "novopen 4 over delivering the insulin dose that was delivered with the priming dose" was not reported.Investigation result: product: novopen 4; batch number: unknown.No investigation was possible, because neither sample nor batch number was available.Manufacturer's comment: on 24-jul-2018: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4).Evaluation summary: investigation result; product: 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: 7722653
• MDR Text Key: 115115833
• Report Number: 9681821-2018-00052
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• 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: 07/05/2018
• 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: INSULIN (INSULIN) SOLUTION FOR INJECTION
• Patient Outcome(s): Hospitalization
• Patient Age: 9 YR
• Patient Weight: 39