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

Model Number N/A

Device Problems Leak/Splash (1354); Unintended Movement (3026)

Patient Problem Hyperglycemia (1905)

Event Date 11/03/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas): patient blood glucose levels higher than usual [blood glucose increased] device is not working properly [device malfunction] the dial on the device was not very clear compared to other pens [device information output issue] the insulin was leaking [device leakage] battery stopped showing how much was given too.[device power source issue] case description: this serious spontaneous case from the united kingdom was reported by a pharmacist as "patient blood glucose levels higher than usual(blood glucose increased)" beginning on (b)(6) 2021, "device is not working properly(device malfunction)" beginning on (b)(6) 2021, "the dial on the device was not very clear compared to other pens(device information output issue)" beginning on (b)(6) 2021, "the insulin was leaking(device leakage)" beginning on (b)(6) 2021, "battery stopped showing how much was given too.(device battery issue)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novorapid (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used-unk, unknown) from unknown start date for "drug use for unknown indication", , novopen echo (insulin delivery device) from unknown start date for "device therapy", , novopen echo (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index was not reported.Medical history was not provided.On (b)(6) 2021 patient's device was not working properly, the dial on the device was not very clear compared to other pens previously used and it appeared that the insulin was leaking from the device hence full dose not being administered and patient blood glucose levels were higher than usual 14.2 (unit was not reported).It was also reported that device battery stopped showing how much was given too.Batch number of novopen echo was kvgy0442 and jvgw0071.Batch number of novorapid was requested.Action taken to novorapid was not reported.Action taken to novopen echo was not reported.The outcome for the event "patient blood glucose levels higher than usual(blood glucose increased)" was unknown.The outcome for the event "device is not working properly(device malfunction)" was not reported.The outcome for the event "the dial on the device was not very clear compared to other pens(device information output issue)" was unknown.The outcome for the event "the insulin was leaking(device leakage)" was not reported.The outcome for the event "battery stopped showing how much was given too.(device battery issue)" was not reported.References included: reference type: e2b authority number.Reference id#: (b)(4).Reference notes: on 25-nov-2021, the case changed status from non-valid to valid as missing patient identifier was reported'.Reporter comment: it was reported that patient had another novopen echo at home and used it.Patients blood glucose levels under control with this device.

Event Description

Case description: investigation result: name: novopen echo®, batch number: kvgy044-2.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.Name: novopen echo®, batch number: jvgw007-1.A visual examination of the returned product was performed.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.It is not possible to reach the memory.Memory display is blank.Visual examination and functional testing were performed.Piston rod is difficult to retracted and all click sounds are missing.Microscopic examination performed.Foreign sticky matter was observed on the dose selector, on the scale drum and on the cartridge holder.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.The results were found to comply with specifications.The device was tested for leakage after insulin delivery with a random cartridge mounted.The results were found to comply with specifications.Scanning of internal pen parts was performed.No visible defects.Microscopic examination performed.There are brown spots on the dose indicator barrel (visible though the diw).The dose setting click is weak, it seems that there is a foreign mattet inside the pen, hindering the pen to work properly.When the dosage selector module is removed it reveals that all four balls (eod and lock balls) are stuck in there positions due to a sticky foreign substance.A tool is needed to remove the balls from the dosage selector.Inside the dosage selector, the electronic module and the connector is covered in a thick brownish substance.There is no doubt that this foreign matter has blocked the electronic switches hence causing the memory display to show two dashes or be blank.The foreign matter inside the pen has been analyzed (report 07012022-127451-1 attached below).The analyse concludes that it seems to be a fluid that has dried out and it is a organic material, carbohydrate (in the report ftir spectra illustrated with maltose).However the exact type of carbohydrate cannot be verified, but there is no doubt that this pen has been exposed for/wetted with a substance e.G.Food or drink that contains carbohydrate sticky matter observed on pen parts (internal or external) e.G.Oily substances.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.Name: novorapid penfill, batch number: ks6cm56.A visual examination of the returned product was performed.It is not possible to test the cartridge for inaccuracy.A pressure test was performed.The cartridge passed the pressure test and no sign of leakage was observed.During examination of the product, no irregularities related to the complaint were detected.A reference sample was examined macroscopically and analysed chemically the reference sample was found to be normal.The results were found to comply with specifications.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.Through investigations, conclusions as below: after check batch production record, no abnormal related leakage were found during filling batch kvg1m66 and inspection batch kvg1m68.After visual inspection on 68 pcs of reference samples for inspection batch kvg1m68, no defect related to leakage cartridge was found.No related deviation,cc or ic regarding the same batch and same nature.Base on above evaluation, there is no indication of any abnormal or process error during filling batch kvg1m66 and inspection batch kvg1m68.During investigation no irregularities related to the complaint was detected on a reference/reserve sample of the batch in question.The batch documentation has been reviewed and found to be normal.A complaint sample has been analysed chemically.The result was within acceptable limits.During examination of the product, no irregularities related to the complaint were detected.Since last submission case updated with the following information: -investigation result updated.-b c d g codes updated.-narrative updated accordingly.Final manufacturer's comment: name: novopen echo®, batch number: kvgy044-2.04-mar-2022: the suspected device novopen echo (batch number: kvgy044-2) 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.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.Name: novopen echo®, batch number: jvgw007-1.04-mar-2022: upon investigation of the returned sample (novopen echo, batch number: jvgw007-1), memory display was found to be blank.Device was found to be functioning normally with new cartridge and needle.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.Microscopic examination revealed foreign matter inside the pen, hindering the pen to work properly.The observed problem could not be related to any novo nordisk processes and is a result of accidental damage during use of the device.H3 continued: evaluation summary: name: novopen echo®, batch number: kvgy044-2.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation has been reviewed and found to be normal.

• 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: 12922708
• MDR Text Key: 286446695
• Report Number: 9681821-2021-00082
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: KVGY044-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2020
• 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: 16 YR
• Patient Sex: Male