MAUDE Adverse Event Report: NOVO NORDISK A/S - MS HJOERRING NOVOFINE 8MM (30G) AUTOCOVER; NEEDLE

Catalog Number 185275

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problems Hypoglycemia (1912); Pain (1994)

Event Type  Injury  

Event Description

Not getting the correct insulin dose when using an autocover needle [incorrect dose administered by device].Considerable drop in blood glucose [blood glucose decreased] finding the injections painful [injection site pain].Case description: this serious spontaneous case from the (b)(6) was reported by a pharmacist via the(b)(4) as "not getting the correct insulin dose when using an autocover needle" and "considerable drop in blood glucose", "finding the injections painful" all with an unspecified onset date, and concerned a patient both (age and gender: not reported) who used novofine 8mm (30g) autocover (needle) from unknown start date as device therapy.Patient's weight, height and body mass index were not reported.Medical history is not provided.It was reported that the patient was not getting the correct insulin dose when the patient was using novofine 8mm (30g) autocover needle.The patient had been steadily increasing the dose and when the needles were changed, it resulted in a considerable drop in the patient's blood glucose (values not reported).The onset date of the events were not reported.Action taken to novofine 8mm (30g) autocover (needle) was not reported.The overall outcome was reported as unknown.This case has been linked with (b)(4) (same reporter, different patient (patient 2).No further information was available at the time of reporting.

Manufacturer Narrative

Investigation results: novofine autocover 30g - batch unknown.No investigation was possible, because neither sample nor batch number was available.This case was re-classified from non-serious to serious on 13-may-2015 by (b)(4) with seriousness criteria as medically significant.Final comment from the manufacturer: 18-may-2015: as none of the needles suspected has been returned to novo nordisk a/s for investigation, and very limited information regarding the handling of the suspected needles was available, it is not possible to identify a clear root-cause for the experienced event and thus find similar cases as (b)(4).However, a search on similar medical events (serious hypoglycaemic events) was performed for the novofine autocover needle covering the period q1 2014 through q1 2015: q1/q3/q4 2014: serious hypoglycaemic events world wide: 0.Reporting rate in events/mill.Sold needles world wide: 0.0.Serious hypoglycaemic events (b)(4): 0.Reporting rate in events/mill.Sold needles (b)(4): 0.0.Q2 2014: serious hypoglycaemic events world wide: (b)(4).Reporting rate in events/mill.Sold needles world wide: (b)(4).Serious hypoglycaemic events (b)(4): 0.Reporting rate in events/mill.Sold needles (b)(4) 0.0.Q1 2015: serious hypoglycaemic events world wide: 0.Reporting rate in events/mill.Sold needles world wide: 0.0.Serious hypoglycaemic events (b)(4): 0.Reporting rate in events/mill.Sold needles (b)(4) 0.0.Novofine autocover 30g - batch unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOFINE 8MM (30G) AUTOCOVER
• Type of Device: NEEDLE
• Manufacturer (Section D): NOVO NORDISK A/S - MS HJOERRING; hjoerring ; DA
• Manufacturer (Section G): NOVO NORDISK A/S, MS HJOERRING; stenager alle 4; hjoerring 9800 ; DA 9800
• Manufacturer Contact: po box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 4795500
• MDR Text Key: 5855947
• Report Number: 9681822-2015-00005
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: K050106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 185275
• Other Device ID Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other