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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 3 DEMI INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S NOVOPEN 3 DEMI INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Retraction Problem (1536); Device Operates Differently Than Expected (2913)
Patient Problem Hyperglycemia (1905)
Event Date 09/30/2016
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) the glycemia recorded 600 mg/dl [hyperglycaemia]; the pen was locked [device use issue]; the pen did not leave medicine in the dosage that was selected [device issue]; the pen did not return. [device use issue]; the piston rod did not come down [device issue]; the piston rod did not fit the penfill. [device issue]. This serious spontaneous case from (b)(6) was reported by a consumer as "the glycemia recorded 600 mg/dl" with an unspecified onset date, "the pen was locked" beginning on (b)(6) 2016, "the pen did not leave medicine in the dosage that was selected" beginning on (b)(6) 2016, "the pen did not return. " beginning on (b)(6) 2016, "the piston rod did not come down" beginning on (b)(6) 2016, "the piston rod did not fit the penfill. " beginning on (b)(6) 2016, and concerned a female patient who was treated with novopen 3 demi (insulin delivery device) from unknown start date due to "type 1 diabetes mellitus". Information on height and weight was not reported. Medical history included type 1 diabetes mellitus. Concomitant medical products: novorapid penfill (insulin aspart) solution for injection, 100 u/ml. Treatment included - insulin(insulin). On (b)(6) 2016 patient reported using novopen 3 demi with novorapid penfill and the pen was locked. The pen did not leave medicine in the dosage that was selected and did not return. Patient could not change the penfill. Patient did a flow verification test but without success. The piston rod did not come down and could not fit the penfill. The push button could be turned. Following, the patient was treated herself with insulin. Patient used novorapid 1 year ago and bought for 6 months ago a novopen 3 demi. Uses 20 iu per day. Action taken to novopen 3 demi was not reported. The outcome for the event "the glycemia recorded 600 mg/dl" was not yet recovered. The outcome for the event "the pen was locked" was not reported. The outcome for the event "the pen did not leave medicine in the dosage that was selected" was not reported. The outcome for the event "the pen did not return. " was not reported. The outcome for the event "the piston rod did not come down" was not reported. The outcome for the event "the piston rod did not fit the penfill. " was not reported.
 
Event Description
Case description: the product was not returned for examination. On 30-sep-2016 patient reported using novopen 3 demi with investigational result: name: novopen® 3 demi. Batch number: aug1456. The product was not returned for examination. A batch trend report has been created. Nothing abnormal was found. The batch documentation was reviewed. No abnormalities relating to the observed problem were found. Nothing abnormal was found. Since last submission of the case the following has been updated: -investigational result. -product tab. -final device report. Final manufacturer comment: on 18-nov-2016 as novopen 3 demi has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected novo pen 3 demi is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case. Evaluation summary: name: novopen® 3 demi, batch number: aug1456 (b)(4): a batch trend report has been created. Nothing abnormal was found. The product was not returned for examination. If possible, please forward the reported product(s) for further investigations. The complaint has been registered in the novo nordisk complaint handling system. (b)(4): the batch documentation was reviewed. No abnormalities relating to the observed problem were found. The batch documentation has been reviewed. Nothing abnormal was found. Name: novorapid® penfill® 5 x penfill® 3 ml - 100 u/ml, batch number: unknown no investigation was possible, because neither sample nor batch number was available. If possible, please forward the reported product(s) for further investigations.
 
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Brand NameNOVOPEN 3 DEMI
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
novoprod novo nordisk inc.
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key6085927
MDR Text Key59459678
Report Number9681821-2016-00035
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
19-938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup
Report Date 10/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/13/2016
Device Model NumberN/A
Device Catalogue Number185258
Device Lot NumberAUG1456
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2011
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: 11/08/2016 Patient Sequence Number: 1
Treatment
NOVORAPID PENFILL (INSULIN ASPART) SOL FOR INJECT
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