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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 Jam (2983)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) hypoglycaemia [hypoglycaemia]. Pen jammed (the piston rod was not moving forward properly) [device mechanical issue]. Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "hypoglycaemia(hypoglycaemia)" with an unspecified onset date, "pen jammed (the piston rod was not moving forward properly)(device mechanical jam)" with an unspecified onset date, and concerned a (b)(6) male patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus". Patient height, weight and body mass index was not reported. Current condition: type 1 diabetes mellitus (duration was not reported). Concomitant products included - novorapid(insulin aspart) solution for injection, 100 iu/ml on an unspecified date, the patient reported that the pen was jammed (piston rod was not moving forward properly) and therefore not transporting enough insulin. Therefore, the patient estimated how much novorapid had to inject and injected himself and then experienced hypoglycaemia with it for which the emergency doctor had to be called. Batch number has been requested. The outcome for the event "hypoglycaemia(hypoglycaemia)" was not reported. The outcome for the event "pen jammed (the piston rod was not moving forward properly)(device mechanical jam)" 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 3400
Manufacturer Contact
p.o. box 846
plainsboro,, NJ 08536
8007276500
MDR Report Key12525084
MDR Text Key273089698
Report Number9681821-2021-00059
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/24/2021 Patient Sequence Number: 1
Treatment
NOVORAPID (INSULIN ASPART)
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