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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); Failure to Deliver (2338)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
(related symptoms if any separated by commas). Hyperglycemia [hyperglycaemia]. Piston is completely loose, does not complete the process [device malfunction]. Pen does not inject the drug [device failure]. This serious spontaneous case from (b)(6) was reported by a consumer as "hyperglycemia(hyperglycemia)" with an unspecified onset date, "piston is completely loose, does not complete the process(device component malfunction)" with an unspecified onset date, "pen does not inject the drug(device failure)" with an unspecified onset date, and concerned a male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy". Patient's height, weight and body mass index were not reported. Current condition: anxiety, alcoholism. Concomitant products included - insulatard hm(insulin human) suspension for injection, 100 iu/ml, sertraline, naltrexone, topiramate on an unknown date, the patient developed hyperglycemia. The reporter did not inform the value of hyperglycemia and was unable to provide more accurate data regarding the medications the patient uses. The patient was hospitalised on an unspecified date in (b)(6) 2021 during which patient was medicated. The pen locks up at the time of application and when it reaches number 10 it does not finish does not inject the drug. The pen spring and flow tests were performed. During the service, the reporter said that she rose a little drop, but the piston is completely loose and does not complete the process. She informs that when she turns the pen upside down, the piston comes out in her hand, when it fits in the mechanism it becomes loose, soft and does not complete the application. The reporter said that the pen has been used for 1 year. On (b)(6) 2021, the patient was discharged. Batch numbers: novopen 4: jvgv305-2. The outcome for the event "hyperglycemia(hyperglycemia)" was recovered. The outcome for the event "piston is completely loose, does not complete the process(device component malfunction)" was not reported. The outcome for the event "pen does not inject the drug(device failure)" was not reported. Preliminary manufacturer's comment: on 14-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 Key12377307
MDR Text Key268479771
Report Number9681821-2021-00047
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
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 08/10/2021
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 NumberJVGV305-2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2019
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
Treatment
INSULATARD HM (INSULIN HUMAN); NALTREXONE (NALTREXONE); SERTRALINE (SERTRALINE); TOPIRAMATE (TOPIRAMATE)
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