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

Model Number N/A

Device Problems Defective Device (2588); Infusion or Flow Problem (2964)

Patient Problems Hyperglycemia (1905); Myocardial Infarction (1969); No Code Available (3191)

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Cardiac issue [cardiac disorder].Heart attack [myocardial infarction].Blood sugar of 48 [blood glucose abnormal].Novopen echo is broken as he stores the needles on his pen [device breakage].Novopen echo is broken as he stores the needles on his pen [wrong technique in device usage process].Case description: this serious spontaneous case from the (b)(6) was reported by a consumer as "cardiac issue" with an unspecified onset date, "heart attack" with an unspecified onset date, "blood sugar of 48" with an unspecified onset date, "novopen echo is broken as he stores the needles on his pen" with an unspecified onset date, and concerned a (b)(6) years old male patient who was treated with novopen echo (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus".Patient's height, weight and body mass index: not reported.Medical history included type 1 diabetes mellitus (duration unknown).Concomitant medications statins (unspecified).It was reported that the top of his novopen echo was broken as he stored the needles on his pen.The patient was recently in the hospital for 9 days for a cardiac issue and he had high blood sugar level of 48 (unit unknown) which caused a heart attack.The patient had an angiogram which showed he had no access to put in a stent, so he has had his medication changed.He was on statins which had been increased to 80 mg and he had been started on ramipril.Action taken to novopen echo was product discontinued.The outcome for the event "cardiac issue" was unknown.The outcome for the event "heart attack" was unknown.The outcome for the event "blood sugar of 48" was unknown.The outcome for the event "novopen echo is broken as he stores the needles on his pen" was not reported.

Event Description

Case description: investigation result: name: novopen echo - batch unknown.No investigation was possible, because neither sample nor batch number was available.Manufacturer's comment: 14-dec-2017 as novopen echo has not been returned to novo nordisk a/s for investigation and only limited information regarding the handling of suspected.Novopen echo is available, it is not possible to identify a clear root-cause of the experienced.Adverse events and thus find similar incidents to the one reported in (b)(4).Evaluation summary: name: novopen echo - batch unknown.No investigation was possible, because neither sample nor batch number was available.

Event Description

On (b)(6) 2017, correction was performed.Since last submission, the case has been corrected with the following.

Event Description

Case description: on 11-jan-2018, correction was performed.Since last submission, the case has been corrected with the following: manufacturing date is unknown.Patient identifier.

• Brand Name: NOVOPEN ECHO
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 7080447
• MDR Text Key: 93710663
• Report Number: 9681821-2017-00062
• 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: consumer,foreign
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: NOT_PROVIDED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR