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

Model Number N/A

Device Problems Defective Component (2292); Failure to Deliver (2338)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Elevated blood glucose value [blood glucose increased].Piston rod did not move forward, no insulin was delivered [device malfunction].Piston rod did not move forward, no insulin was delivered [device failure].Case description: this serious spontaneous case from (b)(6) was reported by a diabetes nurse specialist as "elevated blood glucose value(blood glucose increased)" with an unspecified onset date, "piston rod did not move forward, no insulin was delivered (device component malfunction)" with an unspecified onset date, "piston rod did not move forward, no insulin was delivered (device failure)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index were not reported.Medical history was not provided.On an unknown date, it was reported that as the piston rod of novopen 4 did not move forward, no insulin was delivered and patient had a blood glucose value of 539 mg/dl at lunch time.According to patient pen was approximately 10 years old.Batch numbers: novopen 4: dug0265.Action taken to novopen 4 was not reported.The outcome for the event "elevated blood glucose value(blood glucose increased)" was not reported.The outcome for the event "piston rod did not move forward, no insulin was delivered (device component malfunction)" was not reported.The outcome for the event "piston rod did not move forward, no insulin was delivered (device failure)" was not reported.

Event Description

Case description: investigation result: novopen 4 - batch dug0265.Visual examination and functional testing were performed and the device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge and the piston rod were found normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Since last submission, the case has been updated with the following: -investigation result updated.-device tab, eu/ca tab, device addendum tab updated.-narrative updated accordingly.Final manufacturer's comment: 12-oct-2021: the suspected device novopen 4 has been returned to novo nordisk for evaluation.Investigation is completed.During examination of the product, no irregularities related to the complaint were detected.Since no faults were found in the returned device(novopen 4) and only limited information regarding the handling of suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event and thus not possible to find similar incidents to the one reported in argus case no.(b)(4).H3 continued: evaluation summary: investigation result: novopen 4 - batch dug0265.Visual examination and functional testing were performed and the device was tested with a random cartridge and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge and the piston rod were found normal.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• MDR Report Key: 12518018
• MDR Text Key: 272869799
• Report Number: 9681821-2021-00056
• 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: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: DUG0265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other