MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3 INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Low insulin levels. Pen reported as being defective. Case description: this serious spontaneous case from the united kingdom was reported by a pharmacist as "low insulin levels" and "pen reported as being defective" both with an unspecified onset date and concerned a male patient who was treated with novopen 3 (insulin delivery device) both from an unknown start date for device therapy. Patient's height, weight and body mass index: not reported. Medical history was not provided. Concomitant medication: levemir (insulin detemir) solution for injection,. 0024 mol/l. It was reported that patient was admitted to hospital due to low insulin levels. The drug in the pen was levemir. Pen was also reported as defective when the patient was admitted to hospital. Action taken to novopen 3 was not reported. The outcome for the event "low insulin levels" was not reported. The outcome for the event "pen reported as being defective" was not reported. This case was re-classified from nonserious to serious on 16-dec-2016 due to addition hospitalization for the event "low insulin levels" and "device became defective".

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas), pen hadn't been delivering the correct dose and the patient received a low dose of insulin [incorrect dose administered by device], pen reported as being defective [device defective]. Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "pen hadn't been delivering the correct dose and the patient received a low dose of insulin" and "pen reported as being defective" both with an unspecified onset date and concerned a male patient who was treated with novopen 3 (insulin delivery device) both from an unknown start date for device therapy. Patients wife said that the pen hadn't been delivering the correct dose and the patient received a low dose of insulin resulting in a hospital admission. The outcome for the event "pen hadn't been delivering the correct dose and the patient received a low dose of insulin" was not reported. The outcome for the event "pen reported as being defective" was not reported. Investigation result: name: novopen® 3 batch: unknown. No investigation was possible, because neither sample nor batch number was available. Since last submission the case has been updated with following information: -narrative updated, -investigation result, -final manufacturer comment. Final manufacturer comment: update 23-jan-2017: as novo pen 3 has not been returned to novo nordisk (b)(4) for investigation and only very limited information regarding the handling of suspected novo pen 3 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). Evaluation summary: no investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 3
• 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: 6228260
• MDR Text Key: 64024956
• Report Number: 9681821-2017-00001
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: 19-938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 185290
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/06/2017
• 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: 01/06/2017 Patient Sequence Number: 1

Treatment

LEVEMIR (INSULIN DETEMIR) SOL FOR INJ .0024 MOL/L