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U.S. Department of Health and Human Services

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

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN ECHO INSULIN DELIVERY DEVICE Back to Search Results
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
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.
 
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.
 
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Brand NameNOVOPEN ECHO
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA
MDR Report Key7080447
MDR Text Key258432625
Report Number9681821-2017-00062
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K123766
Number of Events Reported1
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 Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberNOT_PROVIDED
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/09/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/04/2017 Patient Sequence Number: 1
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