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

Catalog Number 185490

Device Problems Failure to Deliver (2338); Improper Device Output (2953); Improper Flow or Infusion (2954)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Type  Injury  

Event Description

Blood glucose levels were so low [hypoglycaemia].Blood glucose values were up to 300 mg/dl [blood glucose increased].Pen is not dosing correctly [incorrect dose administered by device].Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "blood glucose levels were so low", "blood glucose values were up to 300 mg/dl" and "pen is not dosing correctly" all beginning on an unk date, and concerned a (b)(6)-year old female pt who was treated with novopen 4 (insulin delivery device) from unk start date as device therapy.Pt's height weight and body mass index was not reported.Medical history was not provided.It was reported that the patient had fluctuating blood glucose levels during the use of novopen 4.The blood glucose values were up to 300 mg/dl on an unknown date.On an unknown date the patient's blood glucose were so low that the emergency doctor had to come.It was also reported that novopen was not dosing correctly and sometimes it did not deliver anything.Action taken to novopen 4 was not reported.The overall outcome of all events was not reported.

Manufacturer Narrative

Eval summary: investigation result: name: novopen 4, batch number: w40542.Inv-0121576: visual and functional examinations were performed.The cartridge holder was not received as part of the device for evaluation.The device was tested with a random cartridge and a random cartridge holder and a novo nordisk needle was mounted.During testing it was possible to deliver preparation from the cartridge.A batch trend report has been created.Nothing abnormal was found.The piston rod is bent, causing problems when attempting to retract the piston rod into the pen body.The problem is caused by accidental damage during use of the device.Inv-0121581: microscopic examination performed.Confirmed scratches in a pen part and glass fragments were observed in the joint between the cartridge holder and the pen body.This is the result of the use of a cracked or broken cartridge in the device.This explains the user's experience regarding dosage problems.The observed problem could not be related to any novo nordisk processes.The observed fault is a result of accidental damage during use of the device.Foreign matter observed in the dose indicator window.The observed problem could not be related to any novo nordisk processes.The observed fault is a result of accidental damage during use of the device.The piston rod is bent, causing problems when attempting to retract the piston rod into the pen body.The problem is caused by accidental damage during use of the device.Inv-0121581: microscopic examination performed.The dose accuracy was measured by weighing using a random penfill holder and a random penfill.The results were found to comply with specifications.Final comment from the manufacturer: on (b)(6) 2014: the piston rod was found to be bent on the returned pen; however, this did not affect the pens ability to deliver the intended dose.Small glass fragments were found where the cartridge holder connects with the pen body and this indicates that the user has used the pen with a fractured penfill which might have lead to unstable blood glucose.As limited information regarding the patient's handling of the pens, co-morbidities and concomitant medication were present in the case, it is thus not possible deduct a clear root-cause for the experienced event or find cases with similar events as described in (b)(4).

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S; bagsvaerd ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MEDICAL SYSTEMS; brennum park; hilleroed 3400 ; DA 3400
• Manufacturer Contact: po box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 4187721
• MDR Text Key: 5096529
• Report Number: 9681821-2014-00040
• 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: Other,Foreign,Consumer
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2013
• Device Catalogue Number: 185490
• Device Lot Number: VV40542
• Other Device ID Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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): Required Intervention
• Patient Age: 51 YR