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 Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

(related symptoms if any separated by commas).Hyperglycemia [hyperglycaemia].Piston is completely loose, does not complete the process [device malfunction].Pen does not inject the drug [device failure].This serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycemia(hyperglycemia)" with an unspecified onset date, "piston is completely loose, does not complete the process(device component malfunction)" with an unspecified onset date, "pen does not inject the drug(device failure)" 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.Current condition: anxiety, alcoholism.Concomitant products included - insulatard hm(insulin human) suspension for injection, 100 iu/ml, sertraline, naltrexone, topiramate on an unknown date, the patient developed hyperglycemia.The reporter did not inform the value of hyperglycemia and was unable to provide more accurate data regarding the medications the patient uses.The patient was hospitalised on an unspecified date in (b)(6) 2021 during which patient was medicated.The pen locks up at the time of application and when it reaches number 10 it does not finish does not inject the drug.The pen spring and flow tests were performed.During the service, the reporter said that she rose a little drop, but the piston is completely loose and does not complete the process.She informs that when she turns the pen upside down, the piston comes out in her hand, when it fits in the mechanism it becomes loose, soft and does not complete the application.The reporter said that the pen has been used for 1 year.On (b)(6) 2021, the patient was discharged.Batch numbers: novopen 4: jvgv305-2.The outcome for the event "hyperglycemia(hyperglycemia)" was recovered.The outcome for the event "piston is completely loose, does not complete the process(device component malfunction)" was not reported.The outcome for the event "pen does not inject the drug(device failure)" was not reported.Preliminary manufacturer's comment: on 14-aug-2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.No conclusion is reached.

Event Description

Case description: investigational results: name: novopen 4, batch number: jvgv305-2 the product was not returned for examination.No investigation results were provided since last submission the case has been updated with the following -investigational results updated.-imdrf codes has been updated.-is non-reportable has been updated.-narrative updated accordingly.Final manufacturer's comment: (b)(6) 2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation.The batch trend analysis and reference sample examination revealed nothing abnormal.No abnormalities relating to the observed problem were found.With limited information regarding the handling of 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: jvgv305-2 the product was not returned for examination.No investigation results were provided.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed,, ; DA
• MDR Report Key: 12377307
• MDR Text Key: 268479771
• Report Number: 9681821-2021-00047
• 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: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: JVGV305-2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INSULATARD HM (INSULIN HUMAN); NALTREXONE (NALTREXONE); SERTRALINE (SERTRALINE); TOPIRAMATE (TOPIRAMATE); INSULATARD HM (INSULIN HUMAN); NALTREXONE (NALTREXONE); SERTRALINE (SERTRALINE); TOPIRAMATE (TOPIRAMATE)
• Patient Outcome(s): Hospitalization; Other