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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas), patient has been admitted to the hospital [hospitalisation], acute trust her device a novopen 5 has been lost [device issue], they are unable to order novopens from their suppliers as its not something they have ordered before [device dispensing error].Case description: this serious spontaneous case from the united kingdom was reported by a pharmacist as "patient has been admitted to the hospital(hospitalisation)" with an unspecified onset date, "acute trust her device a novopen 5 has been lost(device issue)" with an unspecified onset date, "they are unable to order novopens from their suppliers as its not something they have ordered before(wrong device dispensed)" with an unspecified onset date, and concerned a female patient (age was not reported) who was treated with novopen 5 (insulin delivery device) from unknown start date for "device therapy".Patient height, weight and body mass index were not reported.Medical history was not provided.On an unknown date, patient has been admitted to the hospital and when being transferred from the acute trust her device a novopen 5 has been lost.It was stated that, they were unable to order novopens from their suppliers as it's not something they have ordered before.It was reported that the caller did not have any other information available at the time of reporting.Batch number of novopen 5 has been requested.Action taken to novopen 5 was not reported.The outcome for the event "patient has been admitted to the hospital(hospitalisation)" was not reported.The outcome for the event "acute trust her device a novopen 5 has been lost(device issue)" was not reported.The outcome for the event "they are unable to order novopens from their suppliers as its not something they have ordered before(wrong device dispensed)" was not reported.Preliminary manufacturer's comment: the suspected device (novopen 5) has not been returned to novo nordisk for evaluation.Relevant information regarding device batch number, insulin used with novopen 5, product handling, storage and use of needle are unavailable.No conclusion is reached.This report is for a foreign device that is assessed as "similar" to us marketed novopen echo.Reporter comment: the caller asked if they can send a replacement.The caller then requested that a rep contacts them.

Event Description

Case description: investigation results: name: novopen 5, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission the following has updated: investigation results updated.Annex b,c,d,g codes added.Narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device novopen 5 has not been returned to novo nordisk for evaluation.Batch number of device is not available, no batch trend analysis performed.With limited information regarding the handling of suspected device, it is not possible to identify a clear root-cause of the experienced adverse events.H3 continued: evaluation summary name: novopen 5, batch number: 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 5
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd, ; DA
• MDR Report Key: 11321065
• MDR Text Key: 238726073
• Report Number: 9681821-2021-00010
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization