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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 Device Difficult to Setup or Prepare (1487); Inaccurate Delivery (2339)
Patient Problems Hyperglycemia (1905); Electrolyte Imbalance (2196)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Extremely high blood glucose values [blood glucose increased]. More force was needed to inject [device malfunction]. Novopen echo delivers insulin unreliably [incorrect dose administered by device]. Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "extremely high blood glucose values (blood glucose increased)" with an unspecified onset date, "more force was needed to inject(device component malfunction)" with an unspecified onset date, "novopen echo delivers insulin unreliably(incorrect dose administered by device)" with an unspecified onset date, and concerned a (b)(6)-year-old female patient who was treated with novopen echo (insulin delivery device) from unknown start date for "type 1 diabetes mellitus" and novorapid penfill (insulin aspart) from unknown start date and ongoing for "type 1 diabetes mellitus". Patient's height, weight and body mass index were not reported. Current condition: type 1 diabetes mellitus (for approximately 2 years). No concomitant diseases. Concomitant products included - levemir penfill(insulin detemir) solution for injection,. 0024 mol/l. On an unknown date, the patient experienced extremely high blood glucose values during use of novopen echo. Pen delivered insulin unreliably and the blood glucose value were up to 340 mg/dl. It was reported that more force was needed to inject. On (b)(6) 2020, the patient was in hospital for outpatient treatment, not inpatient. With the help of a replacement pen patient was able to get her blood glucose values under control again. It was reported that the patient was the user of device and has been trained by a health care professional to use. It was reported that patient store the insulin in use at room temperature 20 - 25 °c. Batch number novopen echo: gvge191 novorapid penfill: jr70b40. Action taken to novopen echo was not reported. Action taken to novorapid penfill was not reported. The outcome for the event "extremely high blood glucose values(blood glucose increased)" was recovered. The outcome for the event "more force was needed to inject(device component malfunction)" was not reported. The outcome for the event "novopen echo delivers insulin unreliably(incorrect dose administered by device)" was not reported. Manufacturer's preliminary comment: the suspected device novopen echo has been returned to novo nordisk for investigation. The evaluation of the device is ongoing. Final conclusion on the reported events will be reached after the complete investigation. The young patient ((b)(6) years old) with medical condition of type 1 diabetes mellitus is at increased risk of developing 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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key10128488
MDR Text Key200856729
Report Number9681821-2020-00027
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/11/2019
Device Model NumberN/A
Device Catalogue Number185459
Device Lot NumberGVGE191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2017
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: 06/08/2020 Patient Sequence Number: 1
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