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

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Blood glucose is always high (500 mg/dl) [blood glucose increased].Pen 1 piston rod stuck inside it's place and did not move at all [device mechanical issue].Pen 2 didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving [device failure].Case description: this serious spontaneous case from egypt was reported by a consumer as "blood glucose is always high (500 mg/dl)(blood glucose increased)" with an unspecified onset date, "pen 1 piston rod stuck inside it's place and did not move at all(device mechanical jam)" with an unspecified onset date, "pen 2 didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving(device failure)" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , novopen 4 (insulin delivery device) from unknown start date for "diabetes mellitus", , actrapid penfill (insulin human) solution for injection, 100 iu/ml, (dose, frequency & route used-18 iu, tid, unknown) from unknown start date and ongoing for "diabetes mellitus", , insulatard penfill (insulin human) suspension for injection, 100 iu/ml, (dose, frequency & route used-20 iu, tid, unknown) from unknown start date and ongoing for "diabetes mellitus".Current condition: diabetes mellitus(type and duration not reported), anemia.Concomitant products included - iron, vitamin b1 nos;vitamin b12 nos, calcium, vitamin b2 [riboflavin] on unknown date about 6 or 7 months ago at time of reporting, patient blood glucose reached 500 mg/dl.It was reported that the patient had issues with 2 novopen 4, as they didn't inject the insulin normally as dose button is hardly pressed during injection as patient adjusts the dose counter on 14 iu but it's injects in 5 or 4 times of pressing the dose button pen 1 novopen 4, during the training the mechanical part , the piston rod stuck inside it's place and did not move at all.Pen 2 novopen 4 mechanical part worked normally after adjusting the dose counter to 60 iu and pressing the dose button with a normal movment of the piston rod and by trying a new needle and new pen fill and adjusting dose counter on 8 iu the pen didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving it was reported that, the pen wasn't preserved in the fridge and needle was changed daily then pen training was offered by using new needle and new penfill.There was no recent changes in diet or exercise/physical activity and no co-existing conditions or concomitant medications leading to increased insulin requirements batch numbers: novopen 4: fvg8045.Novopen 4: not reported.Actrapid penfill: asku.Insulatard penfill: asku.Action taken to novopen 4 was reported as not reported.Action taken to novopen 4 was reported as not reported.Action taken to actrapid penfill was not reported.Action taken to insulatard penfill was not reported.The outcome for the event "blood glucose is always high (500 mg/dl)(blood glucose increased)" was not yet recovered.The outcome for the event "pen 1 piston rod stuck inside it's place and did not move at all(device mechanical jam)" was not reported.The outcome for the event "pen 2 didn't inject the insulin as the dose counter returned to 2 iu only and stopped from moving(device failure)" was not reported.References included: reference type: e2b company number.Reference id#: (b)(4).Reference notes: e2b company number.Reporter comment: date and time of the last dose of the suspected product prior to the event was mainly am dose and after one hour of taking it.

Event Description

Case description: current condition: diabetes mellitus, anemia.Batch numbers: novopen 4: fvg8045, novopen 4: asku, actrapid penfill: asku , insulatard penfill: asku.Action taken to novopen 4 was reported as other.Investigation result: product name: novopen® 4 batch number: fvg8045.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Product name: novopen® 4 batch number: fdj8045.The reported batch number was not valid.No conclusion can be made without the sample or a valid batch number.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Name: actrapid® penfill® 3 ml 100iu/ml, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Name: insulatard® penfill® 3 ml 100iu/ml, batch number: unknown.No investigation was possible, because neither sample nor batch number was available.If possible, please forward the reported product(s) for further investigations.Since last submission case updated with the following information: investigation result updated.Narrative updated accordingly.//cnip.Final manufacturer's comment: 09-nov-2021: the suspected device (novopen 4, batch number: fvg8045) has not been returned to novo nordisk a/s for the investigation.The reported batch number is not valid.No batch trend analysis or reference sample analysis performed.No confounding factors identified.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 4.09-nov-2021: the suspected device (novopen 4, batch number: unknown) has not been returned to novo nordisk a/s for the investigation.Batch number of device is not available, no batch trend analysis or reference sample analysis performed.No confounding factors identified.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 4.Event is listed.This single case report is not considered to change the current knowledge of the safety profile of actrapid penfill and insulatard penfill.H3 continued: evaluation summary name: novopen 4, batch number: fvg8045.The product was not returned for examination.If possible, please forward the reported product(s) for further investigations.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed,, 3400 ; DA 3400
• Manufacturer Contact: p.o. box 846; plainsboro,, NJ 08536 ; 8007276500
• MDR Report Key: 12518790
• MDR Text Key: 282486962
• Report Number: 9681821-2021-00057
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/05/2021
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: FVG8045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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
• Treatment: CALCIUM (CALCIUM).; IRON (IRON).; VITAMIN B1 NOS,VITAMIN B12 NOS.; VITAMIN B2 [RIBOFLAVIN] (VITAMIN B2 [RIBOFLAVIN]).
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Sex: Female