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

Model Number	N/A
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Codes	Hyperglycemia (1905); Hypoglycemia (1912)
Date of Event	01/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Low blood sugars [blood glucose decreased].High blood sugars [blood glucose increased].Novopen echo would not depress medication [device failure].Case description: this serious spontaneous case from the united states was reported by a consumer as "low blood sugars(blood sugar decreased)" beginning on (b)(6) 2021, "high blood sugars(blood sugar increased)" beginning on (b)(6) 2021, "novopen echo would not depress medication(device failure)" 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 "device therapy", novopen echo (insulin delivery device) from unknown start date for "device therapy", medical history was not provided.Concomitant products included - novolog penfill(insulin aspart) solution for injection, 100 u/ml, levemir(insulin detemir) solution for injection,.0024 mol/l treatment included - glucagen hypokit(glucagon).On an unknown date novopen echo did not depress medication.It was reported that the backup pen also did not depress the medication either.Due to both of the pens not administering, the patient was taken to the emergency room on (b)(6) 2021 due to blood sugars dropping very quickly from 140mg/dl to 60mg/dl since after eating a cupcake.On (b)(6) 2021, the patient was almost went to the emergency room again due to high blood sugars of 526mg/dl but healthcare provider decided not to.On an unknown date patient also experienced low blood sugars of 146mg/dl dropping down to as low as 60mg/dl for which the patient had possibly received treatment with glucagon hypo kit.It was also reported that the patient had wheezing, eczema, fever, vomiting and a hard time gaining weight while on the product.Batch numbers: novopen echo: kzgy045 novopen echo: jvgv956 investigation results: name: novopen echo, batch: kvgy045 visual examination and functional testing were performed.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 product was found to be normal.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Name: novopen echo, batch: jvgv956 visual examination and functional testing were performed.The memory data in the device has revealed that the memory display has shown two lines after an attempted injection during use.The observed problem was caused by the use of a clogged needle on the pen.After the injection to follow the memory display will function normally again, if the injection needle was changed to a new one.The fault was caused by incorrect handling 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.The dose accuracy was measured by weighing using a random cartridge.The product was found to be normal.The results were found to comply with specifications.References included: reference type: e2b company number.Reference id#: (b)(4).Reference type: mw 3500a mfr.Rpt.#.Reference id#: 9681821-2021-00003.Reference notes: medwatch 3500a mfr.Report number reference type: e2b linked report.Reference id#: (b)(4).Reference notes: same patient and reporter.On 11-mar-2021: novopen echo with new batch number (jvgv956) added as suspect.Final manufacturer's comment: (b)(6) 2021: upon investigation of the returned suspected device novopen echo, batch number kvgy045, it was found to function normally in accordance to set specification and no certain root cause can be identified.No confounding factors.Since no faults were found on the returned device and only very limited information regarding the patient's handling of suspected device is reported in the case, it is therefore not possible to identify a clear root cause for the experienced hyperglycaemia.Final manufacturer's comment: (b)(6) 2021: upon investigating the suspected returned device (novopen echo, batch no.Jvgv956), there was no remark on the piston rod or pen (visual examination).The returned device was found to function normally.The memory data in the device has revealed that the memory display has shown two lines after an attempted injection during use.The observed problem can occur if a needle stays on the device in between dosing, in some cases the insulin will leak out through the needle and create an air gab inside the pen, this may cause the needle to clog, this can lead to incorrect dose and the push button might be hard to depress.The patient will not receive any insulin and could experience a hyperglycemic event.The fault is caused by incorrect handling during use of the device.Continued: evaluation summary: name: novopen echo, batch: jvgv956.Visual examination and functional testing were performed.The memory data in the device has revealed that the memory display has shown two lines after an attempted injection during use.The observed problem was caused by the use of a clogged needle on the pen.After the injection to follow the memory display will function normally again, if the injection needle was changed to a new one.The fault was caused by incorrect handling 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.The dose accuracy was measured by weighing using a random cartridge.The product was found to be normal.The results were found to comply with specifications.

• Brand Name: NOVOPEN ECHO
• Common Device Name: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11633846
• Report Number: 9681821-2021-00018
• Device Sequence Number: 14373577
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K123766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/25/2021
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: JVGV956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR