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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 3 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) unconscious for a few hours [loss of consciousness]. Numbers have faded on pen so unable to work out correct dose [device issue]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "unconscious for a few hours" and "numbers have faded on pen so unable to work out correct dose" both with unspecified onset dates, and concerned a (b)(6) male patient who was treated with suspect drug actrapid hm penfill (fast acting insulin human) and used suspect device novopen 3 (insulin delivery device) both from unknown start dates and ongoing due to diabetes mellitus type 1. Patient's height, weight and body mass index: not reported. Medical history included diabetes mellitus type 1 (duration: not reported). On an unknown date the patient was unconscious for a few hours (details not provided). It was reported that numbers had faded on the novopen, so the patient was unable to work out correct dose. Action taken to actrapid hm penfill and novopen 3 was not reported. The outcome for the event "unconscious for a few hours" was recovered on an unknown date. The outcome for the event "numbers have faded on pen so unable to work out correct dose" was not reported. No further information is available.
 
Event Description
Case description: investigation result: name: novopen 3 red, batch number: jw40009. Visual and functional examinations were performed. A batch trend report has been created. Nothing abnormal was found. The print on the dose indicator barrel is difficult to read due to wear or accumulation of dirt. This may happen during selection of a dose by touching the dose indicator barrel instead of only the dosage selector. This fault is caused by dirt or wear; therefore it occurred during use and regarded as a handling fault. The dose accuracy was measured by weighing using a random penfill cartridge. The results were found to comply with specifications. Microscopic examination performed. Confirmed: the paint from the inside of the pen body has smudged the dose indicator barrel. The smudging of paint is due to as assembly issue. Name: actrapid penfill 3 ml 100 iu/ml, batch number: unknown. No investigation was possible, because neither sample nor batch number was available. Final manufacturer's comment: 18-jan-2016 investigation of the returned pen showed that the pen was able to dose insulin according to specifications, but investigations showed that the print dose indicator barrel was difficult to read due to dirt accumulation. If the patient was not able to see the print on the barrel this might cause the user to misread the numbers and thus choose the incorrect dose, however very limited information regarding the patients handling of the pen was given in the report and accumulation of dirt can be avoided if the storage recommendations in the (instruction for use) ifu are followed. The novo nordisk complaint data base (ccglow) and novo nordisk safety data base (argus) were searched for similar cases as case (b)(4). The search disclosed that no similar cases could be identified in novo nordisk data bases evaluation summary: name: novopen 3 red, batch number: jw40009. (b)(4): visual and functional examinations were performed. A batch trend report has been created. Nothing abnormal was found. The print on the dose indicator barrel is difficult to read due to wear or accumulation of dirt. This may happen during selection of a dose by touching the dose indicator barrel instead of only the dosage selector. This fault is caused by dirt or wear, therefore it occurred during use and regarded as a handling fault. (b)(4): the dose accuracy was measured by weighing using a random penfill cartridge. The results were found to comply with specifications. Microscopic examination performed. Confirmed: the paint from the inside of the pen body has smudged the dose indicator barrel. The smudging of paint is due to as assembly issue.
 
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Brand NameNOVOPEN 3
Type of DeviceINSULIN DELIVERY DEVICE
Manufacturer (Section D)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed, 3400
DA 3400
Manufacturer (Section G)
NOVO NORDISK A/S, MEDICAL SYSTEMS
hilleroed, 3400
DA 3400
Manufacturer Contact
novoprod novo nordisk inc.
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key5344185
MDR Text Key35069529
Report Number9681821-2016-00001
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
19-938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 12/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/08/2004
Device Model NumberN/A
Device Catalogue Number185290
Device Lot NumberJW40009
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/1999
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 01/05/2016 Patient Sequence Number: 1
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