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 Code	Hyperglycemia (1905)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas) blood sugar reading over 500 mg/dl.[blood glucose increased], device did not deliver, unsuccessful troubleshoot [device failure].Case description: this serious spontaneous case from the united states was reported by a consumer as "blood sugar reading over 500 mg/dl.(blood sugar increased)" beginning on (b)(6) 2021, "device did not deliver, unsuccessful troubleshoot(device failure)" beginning on (b)(6) 2021, and concerned a (b)(6) years-old female patient, born in (b)(6) who was treated with novopen echo (insulin delivery device) from (b)(6) 2021 for "device therapy".Medical history was not provided.On (b)(6) 2021, the patient reported that they had a device which did not deliver.As a result, the patient had a high blood sugar reading over 500 mg/dl.Batch numbers: novopen echo: kvg1m78-1 action taken to novopen echo was not reported.On (b)(6) 2021 the outcome for the event "blood sugar reading over 500 mg/dl.(blood sugar increased)" was recovered.The outcome for the event "device did not deliver, unsuccessful troubleshoot(device failure)" was not reported.Preliminary manufacturer's comment: 18-oct-2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation.No conclusion is reached.Reporter comment: patient using ultra fine needles.
Event or Problem Description
Case description: 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 investigation result:.Suspect product: novopen echo batch number: kvg1m781.A visual examination of the returned product was performed.The electronic register was checked.No remarks.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.Final manufacturer's comment: 18-oct-2021: the suspected device novopen echo was returned to novo nordisk and investigation of the device showed that it was working in accordance to specifications.Since no faults were found on the returned device and only very limited information regarding the patients handling of the suspected device is reported in the case, it is not possible to elucidate a clear root cause for the experienced adverse event of hyperglycaemia.However, elderly age of the patient is risk factor for the development of hyperglycaemia.H3 continued: evaluation summary: investigation result: suspect product: novopen echo batch number: kvg1m781.A visual examination of the returned product was performed.The electronic register was checked.No remarks.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.
Event or Problem Description
Event verbatim [preferred term] (related symptoms if any separated by commas).Blood sugar reading over 500 mg/dl.[blood glucose increased].Device did not deliver, unsuccessful troubleshoot [device failure].High blood sugar reading [blood glucose increased].Device did not deliver, unsuccessful troubleshoot [device malfunction].Case description: this serious spontaneous case from the united states was reported by a consumer as "blood sugar reading over 500 mg/dl.(blood sugar increased)" beginning on (b)(6) 2021, "device did not deliver, unsuccessful troubleshoot(device failure)" beginning on (b)(6) 2021, "high blood sugar reading(blood sugar increased)" beginning on (b)(6) 2021, "device did not deliver, unsuccessful troubleshoot(device malfunction)" with an unspecified onset date, and concerned a 89 years old female patient who was treated with novopen echo (insulin delivery device) from (b)(6) 2021 for "diabetes mellitus", current condition: diabetes mellitus (since 1957) (type of diabetes was not reported).On (b)(6) 2021 the outcome for the event "high blood sugar reading(blood sugar increased)" was recovered.The outcome for the event "device did not deliver, unsuccessful troubleshoot(device malfunction)" was not recovered.Since last submission case updated with the following information: patient's date of birth updated.Patient's current condition updated.Indication of suspect product added.Narrative updated accordingly.

• Brand Name: NOVOPEN ECHO
• Common Device Name: 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: 12666199
• Report Number: 9681821-2021-00068
• Device Sequence Number: 11802547
• Product Code: FMF
• UDI-Device Identifier: 00301691854591
• UDI-Public: 00301691854591
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup,Followup
• Report Date (Section B): 10/12/2021

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: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 185459
• Device Lot Number: KVG1M78-1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 11/26/2021; 12/21/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/09/2021; 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 89 YR
• Patient Sex: Female