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

Model Number N/A

Device Problems Defective Component (2292); Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Coma (2417)

Event Type  Injury  

Event Description

No insulin that comes out of the tip [device failure].The piston rod moves quickly [device malfunction].He fell into diabetic coma twice [diabetic coma].Case description: (b)(6).Study description: main objective of the programme is to help patients to understand their diabetes and maintain normal life through qualified educators who offer simple and practical information directly to the patients and also, train patients on how to use their insulin devices and needles etc.Patient's height, weight and body mass index (bmi) was not reported.This serious solicited report from egypt was reported by a consumer as "no insulin that comes out of the tip(device failure)" with an unspecified onset date , "the piston rod moves quickly(device component malfunction)" with an unspecified onset date , "he fell into diabetic coma twice(diabetic coma)" with an unspecified onset date and concerned a male patient (age not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date and ongoing for "device therapy", mixtard 30 hm penfill (insulin human) suspension for injection, 100 iu/ml dose, frequency & route used- unk, unknown from unknown start date and ongoing for "drug use for unknown indication".Medical history was not provided.It was reported that there was no insulin that come out of the tip of the pen and novopen piston rode was moving quickly.It was reported that patient experienced diabetic coma twice because of this pen.The patient was in general reuse the needles and the needle left attached to the pen in between injections.The force needed to inject felt different from normal (easier).Patient used to resuspend the insulin suspension (cloudy insulin) before use.The patient was trained by a health care professional in the use of the novopen.There were no recent change in diet or exercise level.The needle attached to the pen in a 180 degree angle (straight on).The patient had not recently changed from another novopen to the current novopen.Batch numbers: novopen 4: jvgp825, mixtard 30 hm penfill: kr76f34.Action taken to novopen 4 was reported as no change action taken to mixtard 30 hm penfill was reported as no change.The outcome for the event "no insulin that comes out of the tip(device failure)" was not reported.The outcome for the event "the piston rod moves quickly(device component malfunction)" was not reported.The outcome for the event "he fell into diabetic coma twice(diabetic coma)" was not reported.Reporter's causality (novopen 4): no insulin that comes out of the tip(device failure): probable.The piston rod moves quickly(device component malfunction): probable.He fell into diabetic coma twice(diabetic coma): probable.Company's causality (novopen 4) - no insulin that comes out of the tip(device failure): possible.The piston rod moves quickly(device component malfunction): possible.He fell into diabetic coma twice(diabetic coma): possible.Reporter's causality (mixtard 30 hm penfill): no insulin that comes out of the tip(device failure): probable.The piston rod moves quickly(device component malfunction): probable.He fell into diabetic coma twice(diabetic coma): probable.Company's causality (mixtard 30 hm penfill) - no insulin that comes out of the tip(device failure): possible.The piston rod moves quickly(device component malfunction): possible.He fell into diabetic coma twice(diabetic coma): possible.Preliminary manufacturer's comment: 29-oct-2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion is reached.Company comment: diabetic coma is assessed as listed event according to the novo nordisk current ccds in mixtard 30 hm penfill.Relevant information on patient age, duration of diabetes mellitus, complications, therapy details with mixtard 30 penfill, investigation results of suspected products (device and drug), outcome of the event and action taken with suspect product are unavailable for complete causality assessment.This single case report is not considered to change the current knowledge of the safety profile of mixtard 30penfill.

Event Description

Case description: investigational result: name: novopen 4 batch number: jvgp825 the product was not returned for examination.If possible, please forward the reported product(s) for further investigations.Name: mixtard 30 penfill batch number: kr76f34 the product was not returned for examination.If possible, please forward the reported product(s) for further investigations since last submission, the case has been updated with the following: - inv result updated - b, c, d and g codes were added.- narrative updated accordingly final manufacturer's comment: 14-jan-2022: 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.H3 continued: evaluation summary name: novopen 4 batch number: jvgp825 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: 12818824
• MDR Text Key: 285256421
• Report Number: 9681821-2021-00070
• 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,Study,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/05/2024
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: JVGP825
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2019
• 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 Sex: Male