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

Model Number N/A

Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hyperglycemia reaching 278mg/dl [hyperglycaemia].Pen presented defect releasing medicine since first use, no amount of liquid is released.[device failure].Case description: this serious spontaneous case from brazil was reported by a patient family member or friend as "hyperglycemia reaching 278mg/dl(hyperglycemia)" with an unspecified onset date, "pen presented defect releasing medicine since first use, no amount of liquid is released.(device failure)" with an unspecified onset date, and concerned a 11 years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 2 diabetes", patient's height: 143 cm.Patient's weight: 32 kg.Patient's bmi: 15.648687.Dosage regimens: novopen echo: current condition: type 2 diabetes (duration not reported).It was reported that patient had a exchange of novopen echo by nn.On an unknown date, the new pen presented defect releasing medicine since first use, no amount of liquid is released.Performed flow test unsuccessfully.On an unknown date patient experienced hyperglycemia reaching blood glucose(blood glucose) to 278 mg/dl after exchanging novopen echo.Reporter informed that they can not wait 5 days to exchange be performed once this situation was life-threatening for her daughter(not informed why).Batch numbers: novopen echo: mvg7m77-4.Action taken to novopen echo was not reported.The outcome for the event "hyperglycemia reaching 278mg/dl(hyperglycemia)" was not reported.The outcome for the event "pen presented defect releasing medicine since first use, no amount of liquid is released.(device failure)" was not reported.Company comment: (b)(6) 2023: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigation result: name: novopen echo, batch number: mvg7m77-4.The product was not returned for examination.Nonconformity-related documentation was examined.No irregularities recorded and therefore no further action.The batch documentation was reviewed and found to be normal.No abnormalities relating to the observed problem were found.Since last submission, the case has been updated with the following: investigation result added imdrf code added relevant fields updated in eu/ca tab narrative updated accordingly.Final manufacturer's comment: 22-sep-2023: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No abnormalities relating to the observed problem were found in the reference sample analysis.The batch documentation has been reviewed and found to be normal.No other confounding factors identified.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.H3 continued: evaluation summary name: novopen echo, batch number: mvg7m77-4.The product was not returned for examination.Nonconformity-related documentation was examined.No irregularities recorded and therefore no further action.The batch documentation was reviewed and found to be normal.No abnormalities relating to the observed problem were found.

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycemia reaching 278mg/dl [hyperglycaemia].Pen was not dispensing the correct amount [incorrect dose administered by device].Dose estimated by clicks [wrong technique in device usage process].Case description: this serious spontaneous case from brazil was reported by a patient family member or friend as "hyperglycemia reaching 278mg/dl(hyperglycemia)" with an unspecified onset date, "pen was not dispensing the correct amount(incorrect dose administered by device)" with an unspecified onset date, "dose estimated by clicks(wrong technique in device usage process)" with an unspecified onset date, and concerned a 11 years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 2 diabetes", fiasp (insulin aspart) (dose, frequency & route used-unk) from unknown start date for "type 2 diabetes".Dosage regimens: fiasp: on an unknown date, the pen was not dispensing the correct amount and tested it with an employee of yours on the day.Patient used the dialing clicks to estimate the dose of the product.Patient used the instruction manual that comes with the packaging for using novopen.Operating the device at the time of the event was maestro (it's not clear what she meant by that).Batch numbers: fiasp: requested.Action taken to fiasp was not reported.The outcome for the event "pen was not dispensing the correct amount(incorrect dose administered by device)" was not reported.The outcome for the event "dose estimated by clicks(wrong technique in device usage process)" was not recovered.Investigation result: name: fiasp, batch number: unknown no investigation was possible, because neither sample nor batch number was available.Since last submission, the case has been updated with the following: investigation result of fiasp added.Product tab updated (suspect fiasp added).Event tab updated (event device failure changed to incorrect dose administered by the device and wrong technique in device use).Narrative updated accordingly.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: reference type: mw 3500a mfr.Rpt.#.Reference id#: (b)(4).Reference notes: medwatch 3500a mfr.Report number.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S; krogshoejvej 55; bagsvaerd,, 2880 ; DA 2880
• Manufacturer Contact: p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 17698711
• MDR Text Key: 322834172
• Report Number: 9681821-2023-00125
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

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 Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: MVG7M77-4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 01/08/2024
• Supplement Dates FDA Received: 10/06/2023; 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 32 KG