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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); Mechanical Jam (2983)
Patient Problem Hyperglycemia (1905)
Event Date 06/01/2021
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) blood glucose values suddenly started to increase [blood glucose increased] piston gets jammed [device mechanical issue] pen does not function properly [device malfunction] this serious spontaneous case from finland was reported by a nurse as "blood glucose values suddenly started to increase(blood sugar increased)" beginning on (b)(6) 2021, "piston gets jammed(device mechanical jam)" with an unspecified onset date, "pen does not function properly(device malfunction)" with an unspecified onset date, and concerned a elderly patient (age not reported) who was treated with novopen echo (insulin delivery device) from (b)(6) 2020 for "type 1 diabetes mellitus". The patient's height, weight and body mass index was not reported. Dosage regimens: novopen echo: ??-sep-2020 to ??-jun-2021; current condition: type 1 diabetes (duration not reported). Concomitant products included - insulin. The pen has been taken into use in (b)(6) 2020. Since an unspecified date in (b)(6) 2021, the patient's blood glucose values had suddenly started to increase. The insulin cartridges had been changed and blood glucose values decreased for a while, but one day before (from the day of reporting) the value was again 30 mmol/l. On the date of reporting, it was noticed that the pen did not function properly and the piston got jammed. The pen was changed to a new one. Blood glucose increased was reported as recovered. Batch numbers: novopen echo: jvgt681-1. Action taken to novopen echo was reported as no change. On (b)(6) 2021 the outcome for the event "blood glucose values suddenly started to increase(blood sugar increased)" was recovered. The outcome for the event "piston gets jammed(device mechanical jam)" was not reported. The outcome for the event "pen does not function properly(device malfunction)" was not reported. Preliminary manufacturer's comment: (b)(6) 2021: the suspected device (novopen echo) has not been returned to novo nordisk for evaluation. No conclusion is reached. Also relevant information on operator of the device, improper use or storage, training on product usage by health care professional, needle re-use and injection technique are unavailable for complete assessment. Elderly age of the patient (over 80 years) is a significant risk factor for hyperglycaemia.
 
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Brand NameNOVOPEN ECHO
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA
Manufacturer (Section G)
NOVO NORDISK A/S
krogshoejvej 55
bagsvaerd, 2880
DA 2880
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key12141505
MDR Text Key260706098
Report Number9681821-2021-00032
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeFI
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberJVGT681-1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/09/2021 Patient Sequence Number: 1
Treatment
INSULIN (INSULIN) SOLUTION FOR INJECTION
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