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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 Failure to Deliver (2338); Positioning Problem (3009)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
High blood sugar levels (up to 30mmol/l) [blood glucose increased] when pressing the pushbutton, he did not believe piston rod would move forward completely [device malfunction]. Case description: this serious spontaneous case from australia was reported by a consumer as "high blood sugar levels (up to 30mmol/l) (blood glucose increased)" with an unspecified onset date, "when pressing the pushbutton, he did not believe piston rod would move forward completely(device component malfunction)" with an unspecified onset date, and concerned a male patient who was treated with novopen echo (insulin delivery device) from unknown start date and ongoing for "device therapy", the patient's height, weight and body mass index was not reported. Medical history was not provided. On an unspecified date, the patient believed piston rod would not move forward completely when pressing the push button. Patient believed that as he had high blood sugar levels occasionally (of up to 30mmol/l). Batch numbers of novopen echo was not available. Action taken to novopen echo was reported as no change. The outcome for the event "high blood sugar levels (up to 30mmol/l) (blood glucose increased)" was recovered. The outcome for the event "when pressing the pushbutton, he did not believe piston rod would move forward completely(device component malfunction)" was not reported. No further information available. Preliminary manufacturer's comment: 13-aug-2021: the suspected device novopen echo has not been returned to novo nordisk for evaluation. No conclusion is reached.
 
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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 Key12370234
MDR Text Key268231085
Report Number9681821-2021-00045
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
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
Report Date 08/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
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? Device Not Returned to Manufacturer
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: 08/26/2021 Patient Sequence Number: 1
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