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

Model Number N/A

Device Problems No Display/Image (1183); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) uncontrolled blood glucose upto 500 and sometimes more [blood glucose increased] doses applied on the display stopped appearing [device information output issue] the amount of insulin delivered per application was not adequate [incorrect dose administered by device].Case description: this serious spontaneous case from brazil was reported by a nurse as "uncontrolled blood glucose upto 500 and sometimes more(blood glucose increased)" with an unspecified onset date, "doses applied on the display stopped appearing(no image display on device)" with an unspecified onset date, "the amount of insulin delivered per application was not adequate(incorrect dose administered by device)" 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 "type 1 diabetes mellitus", fiasp (insulin aspart) solution for injection, 100 iu/ml, dose, frequency & route used- unk, unknown from unknown start date for "type 1 diabetes mellitus", dosage regimens: novopen echo: (b)(6) 2019.Fiasp: not reported.Current condition: type 1 diabetes mellitus (duration not reported).It was reported that patient used novopen echo since (b)(6) 2019 and has been using it for two years with fiasp.It was reported that on an unknown date, the doses applied on the display stopped appearing, concomitantly, the blood glucose levels were uncontrolled to the point of giving a high (250 and even above 500), when they observed that the amount of insulin delivered per application was not adequate.The reporter informs that the pen stopped showing the doses on the display, he said that he saw in the package insert that the duration of the pen is 5 years, from when it started to be used.It was reported that, they changed the insulin, but the problem remained.They performed the flow test, but suspected that the defect must be in the pen and tried to throw a higher dose into the air, and without success, the medication did not come out.Blood glucose only returned to normal when they acquired a new pen.It is used with fiasp insulin.They started using the pen 2 years ago.Use 1 needle per application, and keep it in the device, but before the next application perform the needle test.Batch numbers: novopen echo: jvgr452-1.Fiasp: asku.Action taken to fiasp was not reported.The outcome for the event "uncontrolled blood glucose upto 500 and sometimes more(blood glucose increased)" was recovered.The outcome for the event "doses applied on the display stopped appearing(no image display on device)" was not reported.The outcome for the event "the amount of insulin delivered per application was not adequate(incorrect dose administered by device)" 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.

Event Description

Case description: investigation result: novopen echo - batch jvgr452-1.A visual examination and functional testing of the returned product were performed.Paint from the pen had smudged onto the dosage selector.The fault had not influence on the functions of the pen.The fault was caused by an error in novo nordisk a/s.It was not possible to reach the memory.Memory display showed 2 lines.The device was disassembled to examine internal parts.Corrosion was observed inside the electronic module.The display showed two lines or had turned blank due to corrosion of the electronics as a kind of liquid has entered the pen.The mechanical function of the pen was not affected by the faulty display but it was not possible to use the dose memory function.The fault was caused by accidental damage during use of the device.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.Furthermore, the dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.Fiasp - batch unknown.No investigation was possible, because neither sample nor batch number was available.Final manufacturer's comment: 03-nov-2021: the suspected device novopen echo has been returned to novo nordisk for evaluation.Upon investigation, device was found to function normally when tested with new cartridge and needle.Electronic display was spoiled due to corrosion in electronic module.The fault was caused by accidental damage during use of the device.However the mechanical part of the pen was not affected by the faulty display.With the available limited information, it is not possible to identify the root cause for the reported hyperglycaemia.Patient's underlying medical condition of type 1 diabetes mellitus is a significant confounding factor for development of hyperglycaemia.H3 continued: evaluation summary: investigation result: novopen echo - batch jvgr452-1.A visual examination and functional testing of the returned product were performed.Paint from the pen had smudged onto the dosage selector.The fault had not influence on the functions of the pen.The fault was caused by an error in novo nordisk a/s.It was not possible to reach the memory.Memory display showed 2 lines.The device was disassembled to examine internal parts.Corrosion was observed inside the electronic module.The display showed two lines or had turned blank due to corrosion of the electronics as a kind of liquid has entered the pen.The mechanical function of the pen was not affected by the faulty display but it was not possible to use the dose memory function.The fault was caused by accidental damage during use of the device.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.Furthermore, the dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.

• 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: 12445669
• MDR Text Key: 279260162
• Report Number: 9681821-2021-00053
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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 Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: JVGR452-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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): Other
• Patient Age: 6 YR
• Patient Sex: Female