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

Model Number N/A

Device Problems Defective Component (2292); Inaccurate Delivery (2339)

Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose values dropped so far that he lost consciousness [hypoglycaemic unconsciousness].The push button was very easy to depress [device malfunction].Patient thought that nothing was delivered, therefore he injected a second time [extra dose administered].Fluctuating blood glucose values [blood glucose fluctuation].Case description: this serious spontaneous case from germany was reported by a pharmacist as "blood glucose values dropped so far that he lost consciousness(hypoglycaemic unconsciousness)" with an unspecified onset date, "the pushbutton was very easy to depress(device component malfunction)" with an unspecified onset date, "patient thought that nothing was delivered, therefore he injected a second time(extra dose administered)" with an unspecified onset date, "fluctuating blood glucose values(blood glucose fluctuation)" with an unspecified onset date, and concerned a male patient who was treated with 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.It was reported that patient had fluctuating blood glucose values during use of novopen echo.As the pushbutton was very easy to depress he thought that nothing was delivered.Patient blood glucose values were elevated and therefore he injected a second time.Patient's blood glucose values dropped so far that patient lost consciousness.On an unknown date patient's blood glucose value was 35 mg/dl and was admitted to hospital.Patient's memory got worse.Batch numbers: novopen echo: gvgf376.The outcome for the event "blood glucose values dropped so far that he lost consciousness(hypoglycaemic unconsciousness)" was recovered with sequelae.The outcome for the event "the pushbutton was very easy to depress(device component malfunction)" was not reported.The outcome for the event "patient thought that nothing was delivered, therefore he injected a second time(extra dose administered)" was not reported.The outcome for the event "fluctuating blood glucose values(blood glucose fluctuation)" 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.

Event Description

Case description: investigation results: name: novopen echo, batch number: gvgf376.The product was not returned for examination.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation was reviewed and found to be normal.Since last submission the case has been updated with the following: investigation result updated.Annex b, c, d, and g code updated.Narrative updated accordingly.Final manufacturer's comment: 28-dec-2021: the suspected device (novopen echo) has not been returned to novo nordisk a/s for the investigation.No confounding factors found.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.H3 continued: evaluation summary: name: novopen echo®, batch number: gvgf376.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.The batch documentation was reviewed.No abnormalities relating to the observed problem were found.The batch documentation was reviewed and found to be normal.

Event Description

Case description: patient's height, weight and body mass index (bmi) were not reported.Investigation results: name: novopen echo®, batch number: gvgf376 the batch documentation has been reviewed and found to be normal.A visual examination of the returned product was performed.The electronic register was checked.Several mitigations codes were present this indicates use of a broken or blocked needle.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 results were found to comply with specifications.The product was found to be normal.Confirmed the memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection the pen will function as normal again if a new injection needle is mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.Since last submission the case has been updated with the following; -b, c imdrf codes were updated, -investigational results updated, -narrative updated accordingly final manufacturer's comment: 22-mar-2022: the suspected device (novopen echo) has been returned to novo nordisk a/s for the investigation.Upon investigation, device was found to be working as intended, no abnormalities detected.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.However, memory data revealed device has been used using blocked needle.It can affect the functioning of device.It is possible that patient administered extra dose of insulin due to this display resulting in hypoglycaemia and its complication.The observed problem was caused by unintended use of the device.H3 continued: evaluation summary name: novopen echo®, batch number: gvgf376 the batch documentation has been reviewed and found to be normal a visual examination of the returned product was performed.The electronic register was checked.Several mitigations codes were present this indicates use of a broken or blocked needle.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 results were found to comply with specifications.The product was found to be normal.Confirmed the memory data in the device revealed that an attempted injection did not turn out to be successful and that this was caused by no flow in the delivery system (e.G.The use of a clogged needle on the pen during use).This also made the memory display warn the user by showing two lines (- -) after the attempted injection.In the injection to follow the attempted but faulty injection the pen will function as normal again if a new injection needle is mounted on the pen immediately before the injection.The observed problem was caused by unintended use of the device.

• 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: 13016968
• MDR Text Key: 285014319
• Report Number: 9681821-2021-00092
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/07/2019
• Device Model Number: N/A
• Device Catalogue Number: 185458
• Device Lot Number: GVGF376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2017
• 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; Hospitalization
• Patient Sex: Male