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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 Problem Device Displays Incorrect Message (2591)
Patient Problem Hypoglycemia (1912)
Event Date 07/01/2021
Event Type  Injury  
Event Description
Serious hypos [hypoglycaemia]. The reader at the top simply showing two dashes [device information output issue] extra dose administered [extra dose administered] this serious spontaneous case from the (b)(6) was reported by a consumer as "serious hypos (hypoglycaemia)" with an unspecified onset date, "the reader at the top simply showing two dashes (device image display issue)" with an unspecified onset date, "extra dose administered (extra dose administered)" with an unspecified onset date, and concerned a male patient age(not reported) who was treated with novopen echo (insulin delivery device) from unknown start date for "diabetes mellitus", , novopen echo (insulin delivery device) from unknown start date for "diabetes mellitus", patient height, weight and body mass index not reported. Current condition: diabetes mellitus(type and duration not reported). On an unknown date over the past 6-9 months the pens have become increasingly unreliable, with the reader at the top simply showing two dashes for extended periods of time. This is an intermittent problem (it will work ok for a period of time an then stop working for a similar length of time). A couple of months ago patient asked his doctor for two replacements (which he prescribed), but within about a week getting exactly the same problems again (in both red and blue pens - one for short acting and one for long acting insulin). Patient thought that it has recently caused to overdose. Also patient experienced serious hypos but a couple of weeks ago patient had forgotten whether he took long lasting insulin in the evening, and pen was simply showing two dashes. Patient was convinced that he had not taken evening dose and taken normal dose (extra dose). Patient was awoken at 5 am by his wife as patient was very agitated and was sweating profusely. Blood sugar was 2. 2 mmol/l. Patient thought that he had double dosed. Batch number for novopen echo red has been requested. Batch number for novopen echo blue has been requested. Action taken to novopen echo was reported as unknown. The outcome for the event "serious hypos (hypoglycaemia)" was not reported. The outcome for the event "the reader at the top simply showing two dashes (device image display issue)" was not reported. The outcome for the event "extra dose administered (extra dose administered)" was not reported. Preliminary manufacturer's comment: on (b)(6) 2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation. No conclusion is reached. Reporter comment: as a follow up on the email below the envelope to return the faulty pens arrived this morning - i can send these back once replacement pens have been sent to my local pharmacy and i have picked them up.
 
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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 Key12365674
MDR Text Key268085729
Report Number9681821-2021-00043
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model NumberN/A
Device Catalogue Number185458
Device Lot NumberHVGJ233-2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2018
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: 08/25/2021 Patient Sequence Number: 1
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