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

Model Number N/A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Hypoglycemia (1912)

Event Date 09/14/2020

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycaemia.Novopen echo shows only two lines (display is not reliable), memory function rarely works anymore [device information output issue] memory function rarely works anymore, which caused to inject twice [extra dose administered].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hypoglycaemia" beginning on (b)(6) 2020, "novopen echo shows only two lines (display is not reliable), memory function rarely works anymore(device information output issue)," with an unspecified onset date, "memory function rarely works anymore, which caused to inject twice(extra dose administered)" with an unspecified onset date, and concerned a (b)(6) years old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus".Patient's height: 165 cm.(b)(6).Patient's bmi: 19.467.Current condition: type 1 diabetes mellitus (2008), hypothyroidism; historical condition: celiac disease, small intestine carcinoma (2008).Concomitant products included fiasp(insulin as part) solution for injection, 100 u/ml, kreon(pancreatin), insulin, l-thyroxine [levothyroxine] (l-thyroxine [levothyroxine]).It was reported that the memory of none of the novopen echo functions several years.Most of the time the pen shows only two lines.On (b)(6) 2020, the patient had hypoglycaemia, and was hospitalized.It was reported that it was possible that the patient injected twice because the display was not reliable.It was reported that memory function rarely works anymore, which may have caused the patient to inject twice, and to get into severe hypoglycaemia.Patient's husband called the ambulance because they did not succeed in increasing the blood sugar again and patient was hospitalized.On unspecified date in (b)(6) 2020, the patient's blood glucose level went up to 470 mg/dl in hospital.On (b)(6) 2020, the patient was discharged.It was also reported that the patient used an already used needle and generally reuses the needles.The patient leaves the needle attached to the pen in between injections.Batch numbers: novopen echo: jvgt502-1.The outcome for the event "hypoglycaemia" was not reported.The outcome for the event "novopen echo shows only two lines (display is not reliable), memory function rarely works anymore (device information output issue)" was not reported.The outcome for the event "memory function rarely works anymore, which caused to inject twice(extra dose administered)" was not reported."in order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e.G.Destructive testing or altering of the medical device).The disassembled medical device will be stored with the same retention period as other complaint samples." reporter comment: most of the time the pen shows only two lines.Most probably this is the reason why she was in the hospital from monday to tuesday due to hypoglycaemia.It is possible that she injected twice because the display is not reliable.

Event Description

Case description: investigation result, product: novopen echo, batch number: jvgt502-1.A visual examination of the returned product was performed.Visual examination and functional testing were performed.The memory display showed two lines and the electronic register could not be reached.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.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The device was disassembled to examine internal parts.Corrosion was observed in the pen electronics.Confirmed: the display shows two lines 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.Since last submission, the following has been updated in the case.Investigation result updated, manufacturer comment updated, narrative updated accordingly.Final manufacturer comment: 30-oct-2020: upon investigation of the returned novopen echo, it was identified that memory function of the device damaged due to corrosion of the electronics as a kind of liquid has entered the pen.The fault is caused by accidental damage during use of the device.The mechanical function of the pen is not affected by the faulty display.In cases where the display turns blank or shows "--" the user is warned that the display is broken and should not be used again.It is possible that patient administered extra dose of insulin due to this display error resulting in hypoglycaemia.H3 continued: evaluation summary.Investigation result: product: novopen echo; batch number: jvgt502-1.A visual examination of the returned product was performed.Visual examination and functional testing were performed.The memory display showed two lines and the electronic register could not be reached.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.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.The device was disassembled to examine internal parts.Corrosion was observed in the pen electronics.Confirmed: the display shows two lines 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.

Event Description

Case description: on 25-mar-2021, an amendment was performed.Since last submission the following information has been amended: the case has been marked as reportable.All the required fields for final reportable incidents filled.Since last submission, the following has been updated in the case.Annex g updated, amendment was performed, narrative updated accordingly.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 10722441
• MDR Text Key: 215356789
• Report Number: 9681821-2020-00048
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: JVGT502-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FIASP (INSULIN ASPART); INSULIN (INSULIN); KREON (PANCREATIN); L-THYROXINE [LEVOTHYROXINE]
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR
• Patient Weight: 53