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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas); increased long-term value (hba1c) [glycosylated haemoglobin increased]; piston rod and push button jam [device issue].Case description: this serious spontaneous case from germany was reported by a pharmacist as "increased long-term value (hba1c)" with an unspecified onset date, "piston rod and push button jam" with an unspecified onset date, and concerned (b)(6) years old female patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to device therapy.Patient's height, weight and body mass index were not reported.Medical history included type 2 diabetes mellitus (duration not reported).Concomitant products included - levemir (insulin detemir) solution for injection,.0024 mol/l.On an unspecified date, the patient had increased long-term value (hba1c) during use of novopen 4.The patient could not inject levemir properly with the novopen 4.The piston rod and the push button were jammed and needle handling was not correct.The patient was treated with levemir flexpens.Action taken to novopen 4 was not reported.Batch number of novopen 4 was available.The outcome for the event "increased long-term value (hba1c)" was not reported.The outcome for the event "piston rod and push button jam" was not reported.

Event Description

Case description: investigation result: product name: novopen 4.Batch number: cug1691.The product was not returned for examination.Since last submission, the following was updated to the case: -investigation result updated.-manufacturer comment updated.-narrative updated accordingly.Manufacturer comment: 22-jan-2019: 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).H3 continued: evaluation summary: investigation result.Product name: novopen 4.Batch number: cug1691.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
• MDR Report Key: 8227147
• MDR Text Key: 132391738
• Report Number: 9681821-2019-00002
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/22/2018
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: CUG1691
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVEMIR (INSULIN DETEMIR); LEVEMIR (INSULIN DETEMIR)
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR