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U.S. Department of Health and Human Services

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

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NOVO NORDISK A/S NOVOPEN INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Mechanical Problem (1384)
Patient Problem Loss of consciousness (2418)
Event Type  Injury  
Event Description
Unconscious [loss of consciousness]. Device failure [device failure]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "unconscious (unconscious)" with an unspecified onset date, "device failure (device failure)" with an unspecified onset date, and concerned a female patient who was treated with novopen (insulin delivery device) from unknown start date for "device therapy", , novorapid penfill (insulin aspart) from unknown start date for "product used for unknown indication" (dose and frequency unknown), patient's height, weight and bmi was not reported. Dosage regimens were not reported. On an unknown date, novorapid penfill device (novopen), failed and the patent was unconscious. Batch numbers was requested. Action taken to novopen was reported as unknown. Action taken to novorapid penfill was not reported. The outcome for the event "unconscious (unconscious)" was unknown. The outcome for the event "device failure (device failure)" was not reported. Company comment: loss of consciousness is assessed as unlisted according to the novo nordisk current ccds on novorapid penfill. Information on final diagnosis, clinical and laboratory investigation results including blood glucose values at the time of event, treatment received and concomitant medication details are not available for complete medical assessment of the case. This single case report is not considered to change the current knowledge of the safety profile of novorapid penfill.
 
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Brand NameNOVOPEN
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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key9604931
MDR Text Key189634576
Report Number9681821-2020-00003
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
PMA/PMN Number
K861686
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 12/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberN/A
Device Catalogue Number185230
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2020
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: 01/19/2020 Patient Sequence Number: 1
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