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

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hyperglycemia (1905); No Code Available (3191)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas): hyperglycaemia above 600mg/dl and acetone in urine [hyperglycaemia]; acetone in urine [urine ketone body present]; novopen 4 is not accurate [device issue]; blood glucose raised again [blood glucose increased]; blood glucose is very low [blood glucose decreased]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycaemia above 600mg/dl and acetone in urine" with an unspecified onset date, "acetone in urine" with an unspecified onset date, "novopen 4 is not accurate" with an unspecified onset date, "blood glucose raised again" with an unspecified onset date, "blood glucose is very low" with an unspecified onset date, and concerned a (b)(6) female patient who was treated with actrapid penfill (insulin human) from unknown start date due to "type 1 diabetes mellitus", insulatard penfill (insulin human) from unknown start date due to "type 1 diabetes mellitus", novopen 4 (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus". (b)(6). Medical history included type 1 diabetes mellitus for 25 days. Concomitant medical products: insulatard(insulin human) vial suspension for injection ongoing, actrapid(insulin human) vial solution for injection, 100 iu/ml ongoing. On an unspecified date the patient presented with too high blood glucose levels +600 mg/dl due to a problem with the novopen 4. At the beginning of treatment with novopen 4 the patient's blood glucose levels were within normal range. Then a few days later it started to rise and went up to +600 mg/dl and the patient had developed acetone in urine. There was no coma and no other complications. A doctor advised to use insulin via vials instead of penfills as the novopen 4 was inaccurate. Here after the blood glucose normalised. The patient started using novopen 4 again as it was more comfortable for the patient. Subsequently the blood glucose started to rise again and treatment with vials was resumed. In the follow-up it was reported that patient was using insulatard penfill with batch er7l815 and doses started with 12 iu at breakfast , 2 iu at lunch , 8 iu at dinner then after one week her blood glucose was not controlled as she fells dizzy and shiver and recover by taking sweets so the doctor changed the dose to 9 at breakfast , and 7 at dinner and then after 1 week he reduced the dose again to 7 iu at breakfast and 5 iu at dinner then the recent dose which is 6 iu at breakfast and 3 iu at dinner and her blood glucose is very low ranged from 60 mg/dl and 120 mg/dl and actrapid penfill with batch no er7p748, doses started with 9 iu breakfast,12 iu at lunch ,7 iu at dinner then after one week became 7 iu/breakfast , 7 iu at lunch and 5 iu at dinner then after 1 week became 6 iu at breakfast , 7 iu at lunch and 10 iu at dinner then the recent last dose is 4 iu at breakfast , 6 at lunch and 3 at dinner action taken to actrapid penfill was not reported. Action taken to insulatard penfill was not reported. Action taken to novopen 4 was temporarily discontinued. The outcome for the event "hyperglycaemia above 600mg/dl and acetone in urine" was recovered. The outcome for the event "acetone in urine" was not reported. The outcome for the event "novopen 4 is not accurate" was not reported. The outcome for the event "blood glucose raised again" was not reported. The outcome for the event "blood glucose is very low" was not reported. Reporter comment: the patient father said that both types of insulins started together 1 month ago and ongoing, he said that when the patient uses the insulin with the same doses by vial the blood glucose became normal.

Event Description

Case description: investigation results: actrapid penfill 3 ml 100iu/ml, batch er7p748. The complaint has been registered in the novo nordisk complaint handling system. The product was not returned for examination. A batch trend report has been created. Nothing abnormal was found insulatard penfill 3 ml 100iu/ml, batch er7l815. The complaint has been registered in the novo nordisk complaint handling system. The product was not returned for examination. The reported batch number (er7l815) was not valid. No conclusion can be made without the sample or a valid batch number. Novopen 4 - batch unknown. No investigation was possible, because neither sample nor batch number was available. Manufacturers comment: 29-dec-2016: as the device (novopen 4) has not been returned to novo nordisk (b)(4) for investigation and only very limited information regarding the handling of 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 (b)(4). Since last submission, the case has been updated with the following: -investigation results for suspected products, -manufacturer comment updated, -narrative updated accordingly.

• 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: novoprod novo nordisk inc. ; p.o. box 846; plainsboro, NJ 08536 ; 8007276500
• MDR Report Key: 6188491
• MDR Text Key: 62796398
• Report Number: 9681821-2016-00042
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 12/20/2016 Patient Sequence Number: 1

Treatment

ACTRAPID (INSULIN HUMAN) SOLUTION FOR INJECTION; INSULATARD (INSULIN HUMAN) SUSPENSION FOR INJ