MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problems Component Missing (2306); Inaccurate Delivery (2339); Defective Device (2588); Device Handling Problem (3265)

Patient Problem Hyperglycemia (1905)

Event Date 05/17/2021

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Hyperglycaemia [hyperglycaemia].Novopen 4 silver in use is not working properly [device malfunction].Missed one dose after pen was not working properly [drug dose omission by device].Could not find some of the pen components [device issue].The patient leaves the needle attached to the pen in between injections [product storage error].This serious spontaneous case from portugal was reported by a pharmacist as "hyperglycaemia(hyperglycaemia)" beginning on (b)(6) 2021, "novopen 4 silver in use is not working properly(device malfunction)" with an unspecified onset date, "missed one dose after pen was not working properly(drug dose omission by device)" with an unspecified onset date, "could not find some of the pen components(device component missing)" with an unspecified onset date, "the patient leaves the needle attached to the pen in between injections(device stored with needle attached)" with an unspecified onset date, and concerned a male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy".Patient's height, weight and body mass index were not reported.Medical history was not provided.Concomitant products included - mixtard 30 penfill(insulin human) suspension for injection, 100 iu/ml.On an unknown date, novopen 4 silver (used for the administration of mixtard 30 penfill) was not working properly.The pharmacist informed that the patient, after suspecting that the pen was not working properly, missed one dose yesterday, which lead to hyperglycaemia (glycaemia level > 500 mg/dl).After missing one dose the patient restarted the treatment with spare pen and recovered from the event.It was reported that in general patient reuses the needles, leaves the needle attached to the pen in between injections.The force needed to inject felt higher than normal the patient does not use the dialling clicks to estimate the dose of the insulin.Patient did not recently change diet or exercise level.The patient attached the needle to the pen in a 180 degree angle.The patient stores the insulin in use at room temperature 20-25 degrees celsius.The patient changed the novopen in use after the event.Batch number of novopen 4 has been requested.Action taken to novopen 4 was no change (used the same pen and recovered).On (b)(6) 2021 the outcome for the event "hyperglycaemia(hyperglycaemia)" was recovered.The outcome for the event "novopen 4 silver in use is not working properly(device malfunction)" was not reported.The outcome for the event "missed one dose after pen was not working properly(drug dose omission by device)" was not reported.The outcome for the event "could not find some of the pen components(device component missing)" was not reported.The outcome for the event "the patient leaves the needle attached to the pen in between injections(device stored with needle attached)" was not reported.Preliminary manufacturer's comment: on (b)(6) 2021: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation.No conclusion is reached.Incorrect handling of the product as evidenced by needle re-use and leaving the device stored with needle attached between injections could have led to device malfunction which affects insulin dosage and could have caused hyperglycaemia.

Event Description

Case description: batch number of novopen 4 was fvg8661.Investigation result: novopen 4 blue - batch fvg8661.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 paint was peeling on the edge of the pen cap and occurred due to accidental damage during use of the device.The error was related to the pen design and considered a cosmetic issue.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.Since last submission case was updated with the following :- "is non-reportable" field updated to "yes"; -batch number of suspect updated; -is device available for evaluation and device returned to manufacturer date added; -device malfunction under device information updated to no; -final report checked in eu/ca device tab; -annex b, c, d, g codes updated in device addendum tab; -manufacturer's comment updated; -nca reference number was added in eu/ca device tab; -narrative updated accordingly.Final manufacturer's comment: 05-jul-2021: the suspected device (novopen 4) has been returned to novo nordisk for evaluation.Upon investigation, device was found to function normally in accordance to specifications.The paint was peeling on the edge of the pen cap which is not related reported events of hyperglycaemia.It is therefore not possible to identify clear root cause for the experienced hyperglycaemia.However, incorrect handling of the product as evidenced by needle re-use and leaving the device stored with needle attached between injections could have contributed to device malfunction and hyperglycaemia.H3 continued: evaluation summary investigation result: novopen 4 blue - batch fvg8661.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 paint was peeling on the edge of the pen cap and occurred due to accidental damage during use of the device.The error was related to the pen design and considered a cosmetic issue.The dose accuracy was measured by weighing using a random cartridge.The results were found to comply with specifications.During examination of the product, no irregularities related to the complaint were detected.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 11982365
• MDR Text Key: 267448122
• Report Number: 9681821-2021-00025
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/02/2021
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: FVG8661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MIXTARD 30 PENFILL (INSULIN HUMAN)
• Patient Outcome(s): Other