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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 08/20/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hospitalization [hospitalisation].Piston rod was broken at the top of the pen [device breakage].Case description: this serious spontaneous case from the united states was reported by a consumer as "hospitalization" beginning on (b)(6) 2019, "piston rod was broken at the top of the pen" 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 due to "device therapy".Medical history was not provided.On an unspecified date, it was reported that the piston rod of novopen echo was broken.On (b)(6) 2019, the patient was hospitalized.Batch number was available.Action taken to novopen echo was reported as unknown.The outcome for the event "hospitalization" was not reported.The outcome for the event "piston rod was broken at the top of the pen" was not reported.Investigation results: name: novopen echo, batch number: hvgm563-2 the product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.Nothing abnormal was found.Manufacturer comment: (b)(6) 2019: as the device (novopen echo) 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: name: (b)(6), batch number: hvgm563-2.The product was not returned for examination.The complaint has been registered in the novo nordisk complaint handling system.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.Nothing abnormal was found.

Event Description

Case description: this serious spontaneous case from the united states was reported by a consumer as "hospitalization (hospitalization)" beginning on (b)(6) 2019, "piston rod was broken at the top of the pen (device breakage)" with an unspecified onset date, and concerned a 9 years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "device therapy".Medical history was not provided.Patient was using humalog with novopen echo.On (b)(6) 2019, the patient was hospitalized prior to use of novopen echo.The patient was diagnosed with diabetic ketoacidosis (dka) and juvenile type 1 diabetes which are still ongoing.On (b)(6) 2019, the caregiver clarified that patient's novopen echo had a broken piston and no medication would dispense out of the pen during priming.As a result had emergency insulin called in as they did not get their scheduled dose.Batch numbers: novopen echo: hvgm563-2.The outcome for the event "hospitalization (hospitalization)" was not reported.The outcome for the event "piston rod was broken at the top of the pen (device breakage)" was not reported.Investigation results: name: novopen echo, batch number: hvgm563-2.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed.Nothing abnormal was found.Investigation results for the returned sample: the electronic register was checked.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing the function of the piston rod was found normal and it was possible to deliver preparation from the cartridge.The product was found to be normal.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.Since last submission the case has been updated with the following: investigation results were updated.Manufacturer's comment updated.Narrative updated accordingly.On 25-oct-2019, follow up information was received and it was reported that the events "hospitalization" was prior to the use of novopen echo.It was also reported that since there was no medication being dispensed out of the broken pen during priming, the patient had to take emergency insulin dose.The event was considered to be only a technical complaint.The reported events were reported not to be related to the novopen echo.This case will therefore be deactivated after this submission.Manufacturer comment: 22-oct-2019: since no faults were found on the returned device (novopen echo) and only very limited information regarding the patient's 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 (b)(4).References included: reference type: mw 3500a mfr.Rpt.#.Reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.Reporter comment: the reported events were reported not to be related to the novopen echo.H3 continued: evaluation summary: investigation results: name: novopen echo, batch number: hvgm563-2.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed.Nothing abnormal was found.Investigation results for the returned sample: the electronic register was checked.Visual and functional examinations were performed.The device was tested with a random cartridge and a novo nordisk needle was mounted.During testing the function of the piston rod was found normal and it was possible to deliver preparation from the cartridge.The product was found to be normal.The results were found to comply with specifications.During examination/test of the product it has not been possible to detect any irregularities.The product was found to be normal.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 9174513
• MDR Text Key: 161800175
• Report Number: 9681821-2019-00068
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (y/n): N
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: HVGM563-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 9 YR