MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYS NOVOPEN ECHO; INSULIN DELIVERY DEVIC

Catalog Number 185458

Device Problem Difficult to Remove (1528)

Patient Problem Myocardial Infarction (1969)

Event Date 01/10/2014

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any by commas) heart attack [myocardial infarction].She could not twist off the cartridge holder.It is stuck [device malfunction].Case description: does the incident represent a serious public health treat? no.This serious spontaneous case reported by a consume from sweden, it concerns a (b)(6)-year-old female pt with type 1 diabetes mellitus who was treated with novorapid flexpen (fast acting insulin aspart) and novorapid penfill (fast acting insulin aspart) using novopen echo (insulin delivery device) and experienced "heart attack" on (b)(6) 2014 and also reported "she could not twist off the cartridge holder.It is stuck" beginning on (b)(6) 2014.Pt's height: 164 cm.Medical history includes type 1 diabetes mellitus since 1957.The pt has reportedly been using novorapid flexpen for several years and in beginning of (b)(6) 2014, the pt switched from novorapid flexpen to novorapid penfill in a novopen echo.On (b)(6) 2014, the pt had a severe heart attack and was admitted to hospital.She underwent a surgery at the thorax ward and stayed in the hospital for a month from an unk date in (b)(6) 2014.The pt reported that she had a heart attack just after she changed her novorapid flexpen to novorapid penfill and novopen echo so she had a hard time to remember how to use the new pen.The pt reported that during the start of the use of novopen echo, she still used her novorapid flexpen sometimes.The pt ws feeling better at the time of reporting but she has not recovered yet.She attended heart gymnastics, heart school and visited her doctor regularly to check her heart.After the heart attach she took several medications, heart medication, anticoagulant, for hypertension and lipidlowering agents.On (b)(6) 2014, when the pt was supposed to change novorapid penfill she could not twist off the cartridge holder and it was suck.She read the leaflet, but it did not work.Action taken to novorapid flexpen, novorapid penfill and novopen echo was unk.The outcome of the event "heart attack" was reported as not yet recovered.The outcome of the event "she could not twist off the cartridge holder.It is stuck" was not reported.Company comment: it is unk if the pt has a pre-existing history fo coronary artery disease, hypertension and dyslipidemia as high risk factors to develop further cardiovascular events.There is nothing other than temporal relationship to suggest a casual relationship with insulin treatment.Diabetics are two or three times more likely to die from cardiovascular causes then people with no history of diabetes, even after controling for other cardiovascular risk factors.Based on the information currently provided in the case, the company does not attribute the event to suspected product - insulin.Huxley r, barzi f, woodward m.Excess risk of fatal coronary heart disease associated with diabetes in men and women: meta-analysis of 37 prospective cohort studies.Bmj 2006; 332(7533): 73-78.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVIC
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYS; hilleroed ; DA
• Manufacturer (Section G): NOVO NORDISK A/S -; krogshoejvej 55; bagsvaerd 2880 ; DA 2880
• Manufacturer Contact: po box 846; plainsboro, NJ 08536 ; 6099875831
• MDR Report Key: 3767440
• MDR Text Key: 4486116
• Report Number: 9681821-2014-00014
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K123766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Type of Report: Initial
• Report Date: 03/17/2014

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 Expiration Date: 06/26/2014
• Device Catalogue Number: 185458
• Device Lot Number: BV40192
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2014
• Initial Date FDA Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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): Hospitalization
• Patient Age: 66 YR
• Patient Weight: 58