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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Failure to Deliver (2338); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 10/01/2018
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) the plunger rod does not always come into contact with the plunger. [device malfunction]. Nurse administering the insulin injection did not consider "plunger" contact and did not inject any insulin [drug dose omission by device]. Case description: this serious spontaneous case from the (b)(6) was reported by a consumer as "the plunger rod does not always come into contact with the plunger. (device component malfunction)" beginning on (b)(6) 2018, "nurse administering the insulin injection did not consider "plunger" contact and did not inject any insulin(drug dose omission by device)" beginning on (b)(6) 2018, and concerned a female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus", nn insulin (insulin unspecified) from unknown start date for "type 1 diabetes mellitus", the patient's height, weight and body mass index was not reported. Dosage regimens: novopen 5: current condition: type 1 diabetes (duration not reported). Historical drug included novorapid flextouch. On an unspecified date in (b)(6) 2018, pen-injectors the plunger rod did not come into contact with the plunger. The nurse administering the insulin injection to the patient did not take this "plunger rod to plunger" contact into account. As a result, the nurse did not inject any insulin. The patient on novopen 5 was hospitalized. (hospitalisation). Batch numbers: novopen 5: unknown. Insulin : unknown. Action taken to novopen 5 was not reported. Action taken to insulin was not reported. The outcome for the event "the plunger rod does not always come into contact with the plunger. (device component malfunction)" was not reported. The outcome for the event "nurse administering the insulin injection did not consider "plunger" contact and did not inject any insulin(drug dose omission by device)" was not reported. This report includes a foreign device (novopen 5) that is assessed as "similar" to us marketed novopen echo. Reporter comment: the patient mentioned that the space between the plunger rod and rod is very common in the aforementioned pen-injectors, and that generally healthcare professionals at the hospital do not seem to be aware of this. As a result, they might unknowingly fail to inject insulin.
 
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Brand NameNOVOPEN 5
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S
bagsvaerd,,
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 Key13050633
MDR Text Key288300440
Report Number9681821-2021-00095
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
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