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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 Improper or Incorrect Procedure or Method (2017); Defective Component (2292); Failure to Deliver (2338)
Patient Problem Hyperglycemia (1905)
Event Date 11/01/2020
Event Type  Injury  
Event Description
Hyperglycemia [hyperglycaemia]. Novopen4 the dose button could not pressed [device malfunction]. Novopen 4 did not work normally [device defective]. Novopen4 did not inject the insulin [device failure]. Patient used dialling clicks to estimate the dose of the insulin [wrong technique in product usage process]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycemia(hyperglycemia)" beginning on (b)(6) 2020, "novopen4 the dose button could not pressed(device component malfunction)" beginning on (b)(6) 2020, "novopen 4 did not work normally(device defective)" beginning on (b)(6) 2020, "novopen4 did not inject the insulin(device failure)" beginning on (b)(6) 2020, "patient used dialling clicks to estimate the dose of the insulin(wrong technique in product usage process)" 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 "diabetes mellitus" and actrapid penfill (insulin human) solution for injection, 100 iu/ml (dose, frequency & route used - unk (since 8 years), unknown) (therapy dates - ongoing) from unknown start date and ongoing for "diabetes mellitus", the patient height, weight and body mass index were not reported. Current condition: diabetes mellitus (type and duration not reported). The reporter complained that on an unknown date of (b)(6) 2020 (reported as a month ago), the patient suffered from hyperglycemia as his blood level glucose up to 630 mg/dl when he used actrapid as the novopen 4 did not work normally. Patient complained that his novopen 4 did not inject the insulin as the dose button could not pressed although the dose button pressed normally when he removed the penfill and the needle. Patient was offered pen training and during the training the piston rod did not move for several times when we check the mechanical part and adjusted the dose counter on 60 iu and pressed it the piston rod did not move. Patient has been using actrapid from 7 years and he stopped taking it one week before the event as the novopen 4 was not working normally. It was also reported that the patient used dialling clicks to estimate the dose of the insulin. In general patient reused the needles. Needle(unspecified) was attached to the pen in between injections, the force needed to inject was normal, the patient haven't been recently changed your diet or exercise level, the patient haven't changed from another novopen to the current novopen. Batch numbers: actrapid penfill: asku, novopen 4: fvg7971. Action taken to actrapid penfill was reported as no change. Action taken to novopen 4 was product discontinued due to adverse event (ae). References included: reference type: e2b company number. Reference id#: (b)(4). Preliminary manufacturer's comment: 21-dec-2020: the suspected device (novopen 4) has not been returned to novo nordisk for evaluation. No conclusion has been reached. Product handling error such as needle re-use, leaving the needle attached to device between injections, using dialing clicks to estimate the insulin dosage are significant risk factors which could have lead to device malfunction and cause variation in drug delivered. Additionally stopping the administration of insulin for one week could have lead to hyperglycaemia.
 
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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 Key11066951
MDR Text Key229816030
Report Number9681821-2020-00066
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeEG
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
Report Date 12/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/04/2021
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberFVG7971
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/23/2020 Patient Sequence Number: 1
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