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

Model Number N/A

Device Problem Defective Device (2588)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

2 pens have the same defect, the pluger is loose and has a loose spring [device loosening].Pen was not working [device failure].The pluger is loose, making it very difficult to apply [device difficult to use] had days that could not apply because the pens did not work [drug dose omission by device].Case description: (b)(6).Study description: trial title: to support the patient in the beginning of treatment with novo nordisk products for diabetes mellitus and obesity.The patient is instructed on how to use, transport and store the products, and receives orientation by phone, site or in person by a nurse.This serious solicited report from (b)(6) was reported by a consumer as "blood glucose went to 500/600(blood glucose increased)" with an unspecified onset date , "2 pens have the same defect, the pluger is loose and has a loose spring(device loosening)" with an unspecified onset date , "pen was not working(device failure)" with an unspecified onset date , "the pluger is loose, making it very difficult to apply(device difficult to use)" with an unspecified onset date , "had days that could not apply because the pens did not work(drug dose omission by device)" with an unspecified onset date and concerned a elderly female patient who was treated with novolin n penfill (insulin human) suspension for injection, 100 iu/ml, (dose, frequency & route used- unk, unknown) from unknown start date for "product used for unknown indication", , novopen 4 (insulin delivery device) from unknown start date for "device therapy", , novopen 4 (insulin delivery device) from unknown start date for "device therapy".Medical history was not provided.On an unknown date, the patient reported that two pens (batch unknown) have the same defect, the plunger was loose, making it very difficult to apply and had days that could not apply because the pens did not work.On an unknown date, as the pen was not working, blood glucose went to 500/600 (date was not informed ) and patient went to the hospital (not informed how many hours stayed at the hospital).At the hospital they questioned whether a pen was working, when they got home, they identified that a pen was not working.The test flow was performed for the first time buy unsuccessfully, the button did not return to 0 and the medicine did not come out but the test flow was performed successfully on the second time, the button returned to 0 and the medicine came out.Batch numbers requested.Action taken to novolin n penfill was not reported.Action taken to novopen 4 was not reported.The outcome for the event "blood glucose went to 500/600(blood glucose increased)" was unknown.The outcome for the event "2 pens have the same defect, the pluger is loose and has a loose spring(device loosening)" was unknown.The outcome for the event "pen was not working(device failure)" was unknown.The outcome for the event "the pluger is loose, making it very difficult to apply(device difficult to use)" was unknown.The outcome for the event "had days that could not apply because the pens did not work(drug dose omission by device)" was unknown.Reporter's causality (novolin n penfill) - blood glucose went to 500/600(blood glucose increased): unknown.2 pens have the same defect, the pluger is loose and has a loose spring(device loosening): unknown.Pen was not working(device failure): unknown.The pluger is loose, making it very difficult to apply(device difficult to use): unknown.Had days that could not apply because the pens did not work(drug dose omission by device): unknown.Company's causality (novolin n penfill) - blood glucose went to 500/600(blood glucose increased): unlikely.2 pens have the same defect, the pluger is loose and has a loose spring(device loosening): possible.Pen was not working(device failure): possible.The pluger is loose, making it very difficult to apply(device difficult to use): possible.Had days that could not apply because the pens did not work(drug dose omission by device): possible.Reporter's causality (novopen 4) - blood glucose went to 500/600(blood glucose increased): unknown.2 pens have the same defect, the pluger is loose and has a loose spring(device loosening): unknown.Pen was not working(device failure): unknown.The pluger is loose, making it very difficult to apply(device difficult to use): unknown.Had days that could not apply because the pens did not work(drug dose omission by device): unknown.Company's causality (novopen 4) - blood glucose went to 500/600(blood glucose increased): unlikely.2 pens have the same defect, the pluger is loose and has a loose spring(device loosening): possible.Pen was not working(device failure): possible.The pluger is loose, making it very difficult to apply(device difficult to use): possible.Had days that could not apply because the pens did not work(drug dose omission by device): possible.Reporter's causality (novopen 4) - blood glucose went to 500/600(blood glucose increased): unknown.2 pens have the same defect, the pluger is loose and has a loose spring(device loosening): unknown.Pen was not working(device failure): unknown.The pluger is loose, making it very difficult to apply(device difficult to use): unknown.Had days that could not apply because the pens did not work(drug dose omission by device): unknown.Company's causality (novopen 4) - blood glucose went to 500/600(blood glucose increased): unlikely.2 pens have the same defect, the pluger is loose and has a loose spring(device loosening): possible.Pen was not working(device failure): possible.The pluger is loose, making it very difficult to apply(device difficult to use) : possible had days that could not apply because the pens did not work(drug dose omission by device): possible.Investigational results- suspect product-novolin n penfill 3 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.Suspect product-novopen 4.Batch number-hvgk937-2, kvgy300-1.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.Final manufacturer's comment: 03-dec-2021: the suspected device novopen 4 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 4.Company comment: events are listed.This single case report is not considered to change the current knowledge of the safety profile of novolin n penfill.

• 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: 12983322
• MDR Text Key: 287274179
• Report Number: 9681821-2021-00088
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: HVGK937-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• 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): Hospitalization
• Patient Sex: Female