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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 Problem Mechanical Problem (1384)
Patient Problem Hypoglycemia (1912)
Event Date 06/26/2019
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) severe hypoglycemia [hypoglycaemia]. Device was not working properly, injection button is hard to depress [device malfunction]. Needle is kept attached to the pen [product storage error]. Case description: this serious spontaneous case from portugal was reported by a consumer as "severe hypoglycemia" beginning on (b)(6) 2019, "device was not working properly, injection button is hard to depress" with an unspecified onset date, "needle is kept attached to the pen" with an unspecified onset date, and concerned a (b)(6)-year-old male patient who was treated with novopen 4 (insulin delivery device) from unknown start date due to "device therapy" and novopen 4 (insulin delivery device) from unknown start date due to "device therapy". Patient's height, weight and body mass index (bmi) were not reported. Medical history was not provided. Concomitant products included - mixtard 30 penfill (insulin human) suspension for injection, 100 iu/ml, actrapid penfill (insulin human) solution for injection, 100 iu/ml on (b)(6) 2019, patient experienced an episode of severe hypoglycemia and emergency medical team (emt) was called for assistance. An emt's nurse measured a blood glucose level of 30 mg/dl with their device. The nurse also measured the patient blood glucose level with the patient's device and the measured level was 70mg/dl. It was reported that nurse said the patient's device was not working properly. The patient used mixtard 30 penfil in the morning (24 u) and at night (26 u). Patient has the indication to administer actrapid penfill before lunch (5 u). It was also reported that novopen 4 silver and novopen 4 blue were not working properly, injection button was hard to depress. The patient said his values are now normal and that the last measured blood glucose level was 180 mg/dl. The patient on follow up confirmed that he is recovering and the blood glucose values were measured to be 115mg/dl. The patient said that never did an additional administration, never performing two consecutive administrations. The patient could not confirm regarding the needles, regarding how he uses them, the patient said that sometimes he uses the same needle more than once and in these situations the needle is kept attached to the pen between injections. Batch number was reported. On (b)(6) 2019 the outcome for the event "severe hypoglycemia" was recovered. The outcome for the event "device was not working properly, injection button is hard to depress" was not reported. The outcome for the event "needle is kept attached to the pen" was not reported.
 
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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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key8826139
MDR Text Key152362914
Report Number9681821-2019-00045
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 06/27/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2019
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberEVG2802-4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2015
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: 07/25/2019 Patient Sequence Number: 1
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