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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Defective Component (2292); Defective Device (2588); Improper Flow or Infusion (2954)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
(related symptoms if any separated by commas). Blood sugar and it was 29 [hyperglycaemia]. Black piece in the pen is not quite stable [device issue]. Pen is not giving the right dose [incorrect dose administered by device]. Faulty pen [device defective]. This serious spontaneous case from (b)(6) was reported by a consumer as "blood sugar and it was 29(hyperglycemia)" with an unspecified onset date, "black piece in the pen is not quite stable(device component issue)" with an unspecified onset date, "pen is not giving the right dose(incorrect dose administered by device)" with an unspecified onset date, "faulty pen(device defective)" with an unspecified onset date, and concerned a male patient age (not reported) who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", novorapid (insulin aspart) solution for injection, 100 iu/ml (dose, frequency & route used - 10 units, unknown) from unknown start date for "drug use for unknown indication", patient height, weight and body mass index not reported. Medical history was not provided. On an unknown date patient experienced hyperglycaemia and patient was hospitalized. The black piece in the pen was not quite stable and it has clicked a couple of times and thought maybe the pen was not giving the right dose. It may be a faulty pen as something was wrong with the black piece as sometimes insulin doesn't come out and he doesn't inject insulin therefore could be a problem pen that could only be giving 2 units. Patient gave himself 10 units of novorapid. The blood sugar was tested which was high and his blood sugar was 22-25 (units not reported) and it kept going up and after one hour was 29(units not reported) when it should be coming down. It was now 11. 5(units not reported) at 10 past 2 which was a long time for it to come down. Batch number for novopen 4 has been requested. Batch number for novorapid has been requested. Action taken to novorapid was not reported. The outcome for the event "blood sugar and it was 29(hyperglycemia)" was unknown. The outcome for the event "black piece in the pen is not quite stable(device component issue)" was unknown. The outcome for the event "pen is not giving the right dose(incorrect dose administered by device)" was not reported. The outcome for the event "faulty pen(device defective)" was not reported. Preliminary manufacturer's comment: on 18-aug-2021: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation. No conclusion is reached.
 
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Brand NameNOVOPEN 4
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed,
DA
Manufacturer (Section G)
NOVO NORDISK A/S, MEDICAL SYSTEMS
brennum park
hilleroed, 3400
DA 3400
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key12377587
MDR Text Key268479213
Report Number9681821-2021-00046
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUK
PMA/PMN Number
20-986
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 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberXUG0353
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
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
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: 08/27/2021 Patient Sequence Number: 1
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