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

Model Number N/A

Device Problems Deflation Problem (1149); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Case description: investigation results: name: novopen® 4, batch number: cug2199. The product was not returned for examination. The complaint has been registered in the novo nordisk. Complaint handling system. The batch documentation was reviewed. No abnormalities relating to the function : cannot deliver were found. The batch documentation has been reviewed. Nothing abnormal was found. Since last submission the case was updated with the following information: investigation results updated. Manufacturer comments were updated. Final manufacturer's comment: 10-aug-2017: as the device novopen 4 has not been returned to novo nordisk a/s for investigation and only limited information regarding the handling of the suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case (b)(4). The reported events are listed according to reference documents for novorapid penfill and levemir penfill. Continued: evaluation summary: name: novopen® 4, batch number: cug2199 (b)(4): the product was not returned for examination. The complaint has been registered in the novo nordisk complaint handling system. (b)(4):the batch documentation was reviewed no abnormalities relating to the function : cannot deliver were found. The batch documentation has been reviewed. Nothing abnormal was found.

Event Description

Event verbatim, blood sugars were 26 something [blood glucose abnormal], nothing was coming out of her pen [device failure]. Case description: this serious spontaneous case from the (b)(6) was reported by a consumer as "blood sugars were 26 something" with an unspecified onset date, "nothing was coming out of her pen" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with novorapid penfill (insulin aspart) from unknown start date due to "type 2 diabetes mellitus", levemir penfill (insulin detemir) from unknown start date due to "type 2 diabetes mellitus" and novopen 4 (insulin delivery device) from unknown start date due to "type 2 diabetes mellitus". Patient's height, weight and body mass index (bmi) were not reported. Medical history included type 2 diabetes (since (b)(6)). Concomitant products included - novofine (31g)(needle). The patient reported that she always does a test shot before injection insulin. The patient stated that she was using novofine 31g needles and was changing needles before each injection. On an unknown date at lunch time, the patient checked her sugars were fine. And after some time the patient felt ill, like collapsing and slept for 2-3 hours. Later after waking up, the patient checked her blood sugars which showed 26 something (units not reported). According to the patient nothing was coming out of her pen. The test shot was fine, but nothing must have come thought when injecting. The patient stated that the pharmacy said that the novopen 4 was recalled, and she was not told about it. She stated that she could not trust the pens and that she is considering going to her solicitor, but she does not want to bother with it, but feels she has to due to the seriousness of what happened. The patient stated that she is willing to return the pen "eventually". The patient stated that she has been insulin dependant for 52 years, and has never experienced this before. Action taken to novorapid penfill was not reported. Action taken to levemir penfill was not reported. Action taken to novopen 4 was not reported. The outcome for the event "blood sugars were 26 something" was unknown. The outcome for the event "nothing was coming out of her pen" was not reported. Company comment: the reported events are listed according to reference documents for novorapid penfill and levemir penfill. This is the initial report to the fda for this report.

• 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: novo nordisk inc.; p.o. box 846; plainsboro 08536 ; 8007276500
• MDR Report Key: 6690931
• MDR Text Key: 257085753
• Report Number: 9681821-2017-00030
• 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: 06/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/29/2018
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: CUG2199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/06/2017 Patient Sequence Number: 1