MAUDE Adverse Event Report: NOVO NORDISK A/S, NOVOPEN 5; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Mechanical Jam (2983); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) pens stopped working and was not functioning, experienced some problems.[complication associated with device] tried to do their insulin with the novopen echo and novopen 5 and it stopped working and was not functioning [device failure] the black plunger head did not appear to move in both instances [device malfunction] this serious spontaneous case from the (b)(6) was reported by a nurse as "pens stopped working and was not functioning, experienced some problems.(complication associated with device)" with an unspecified onset date, "tried to do their insulin with the novopen echo and novopen 5 and it stopped working and was not functioning(device failure)" with an unspecified onset date, "the black plunger head did not appear to move in both instances(device component malfunction)" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy", novopen 5 (insulin delivery device) from unknown start date for "device therapy", patient's height: (b)(6) patient's weight: (b)(6).Patient's bmi: 37.72972530.Current condition: type 2 diabetes(since (b)(6) 2002).Concomitant products included - novorapid penfill(insulin aspart) solution for injection, 100 iu/ml, levemir penfill(insulin detemir) solution for injection,.0024 mol/l on an unspecified date patient tried to do their insulin with the novopen echo and novopen 5 and it stopped working and was not functioning and patient experienced some problems.The novopen 5 unable to get any insulin consistently, ie it worked once.The black plunger head did not appear to move in both instances.Batch numbers: novopen echo: unknown novopen 5: jvgx587.Action taken to novopen echo was not reported.Action taken to novopen 5 was not reported.The outcome for the event "pens stopped working and was not functioning, experienced some problems.(complication associated with device)" was recovering/resolving.The outcome for the event "tried to do their insulin with the novopen echo and novopen 5 and it stopped working and was not functioning(device failure)" was recovering/resolving.The outcome for the event "the black plunger head did not appear to move in both instances(device component malfunction)" was not reported.Preliminary manufacturer's comment: (b)(6) 2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No conclusion is reached.(b)(6) 2021: the suspected device novopen 5 has been returned to novo nordisk for evaluation.Investigation is ongoing.With preliminary examination, the product was found to be normal.It was not possible to detect the alleged fault.Reporter comment: patient using insulin for about 7 years and never experienced problems before.This report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo".

Event Description

Investigation result: novopen echo - batch unknown no investigation was possible, because neither sample nor batch number was available.Novopen 5 - batch jvgx587: visual examination and functional testing were performed.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.During examination of the product, no irregularities related to the complaint were detected.Since last submission, the case was updated with the following: investigation result updated."is non-reportable" field updated.Final report checked in eu/ca device tab.B, c, d, g codes updated in device addendum tab.Manufacturer's comment updated.Final manufacturer's comment: novopen echo: 21-jul-2021: the suspected device (novopen echo) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available, no batch trend analysis performed.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 echo.However, elderly age of the patient and obesity are significant confounding factors for product handling error leading to device malfunction and device failure.Final manufacturer's comment: novopen 5: 21-jul-2021: the suspected device (novopen 5) has been returned to novo nordisk and investigation of the device showed that it was working in accordance to specifications.It is therefore not possible to identify a clear root cause in relation to the functionality of novopen 5.However, elderly age of the patient and obesity are significant confounding factors for product handling error leading to device malfunction and device failure."this report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo".H3 continued: evaluation summary investigation result: novopen 5 - batch jvgx587 visual examination and functional testing were performed.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.During examination of the product, no irregularities related to the complaint were detected.

• Brand Name: NOVOPEN 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S,; bagsvaerd,, ; DA
• MDR Report Key: 12181060
• MDR Text Key: 268071743
• Report Number: 9681821-2021-00035
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K123766
• 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: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/14/2021
• Device Model Number: N/A
• Device Lot Number: JVGX587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVEMIR PENFILL (INSULIN DETEMIR; NOVORAPID PENFILL (INSULIN ASPART)
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 93