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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 Problems Crack (1135); Appropriate Term/Code Not Available (3191)
Patient Problems Cataract (1766); Glaucoma (1875); Hyperglycemia (1905); Retinal Injury (2048); Visual Impairment (2138)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Glass haemorrhage to maintain the retina [retinal haemorrhage]. Blindness [blindness]. High blood glucose level [blood glucose increased]. Piston rod of novopen 3 (yug0804) did not press on the penfill [device malfunction]. Penfill holder of novopen 3 (yug0804) was broken [device breakage]. Np3 which did not inject his dose [device failure]. Case description: this serious spontaneous case from (b)(6) was reported by a consumer as "glass haemorrhage to maintain the retina" with an unspecified onset date, "blindness" with an unspecified onset date, "high blood glucose level" with an unspecified onset date, "piston rod of novopen 3 (yug0804) did not press on the penfill" with an unspecified onset date, "penfill holder of novopen 3 (yug0804) was broken" with an unspecified onset date, "np3 which did not inject his dose" with an unspecified onset date, and concerned a (b)(6)-year-old male patient who was treated with mixtard 30 hm penfill (insulin human) from unknown start date and ongoing due to "diabetes mellitus" (regimen #1 dose and frequency 15 u, bid, regimen #2 dose and frequency 7-8u/morning & 12 u/afternoon), novopen 3 (insulin delivery device) from unknown start date due to "device therapy", novopen 3 (insulin delivery device) from unknown start date due to "device therapy". Patient's height: (b)(6); patient's weight: (b)(6); patient's body mass index: not reported. Medical history included diabetes mellitus (since 200 and type unknown), hypertension and eye pressure. Patient was not suffering from any other chronic diseases. Pre-treatment included: diamicron. Concomitant products included - concor (bisoprolol fumarate) ongoing , trental (pentoxifylline) ongoing, octatron (ascorbic acid, betacarotene, bioflavonoids, biotin, molybdenum amino acid chelate, selenium amino acid chelate, tocopherol, zinc amino acid chelate) ongoing and twinzol (dorzolamide hydrochloride, timolol maleate) ongoing. On an unknown day, novopen 3 (tug0329) piston rod did not press on the penfill, however, it moved normally out of the mechanical part when pressed on the dose button without putting the penfill. In addition to this, the penfill holder of novopen 3 (yug0804) was also broken. On an unknown date (2 months and 10 days ago), the patient underwent a surgery in both of eyes to change the eye glass due to glass haemorrhage to maintain the retina and that surgery was due to high blood glucose level due to the problem in his novopen 3 which did not inject the dose and patient is now prevented from vision by the order of hcp's instructions and said that the patient was blind until further interference from the ophthalmologist. Patient's average random blood glucose level now ranged between 100-270 mg/dl and patient always tried to be careful to keep it between 100-120 mg/dl. Batch numbers of all suspect products were available. Action taken to mixtard 30 hm penfill was not reported. Action taken to novopen 3 was not reported. Action taken to novopen 3 was not reported. The outcome for the event "glass haemorrhage to maintain the retina" was not yet recovered. The outcome for the event "blindness" was not yet recovered. The outcome for the event "high blood glucose level" was not reported. The outcome for the event "piston rod of novopen 3 (yug0804) did not press on the penfill" was not reported. The outcome for the event "penfill holder of novopen 3 (yug0804) was broken" was not reported. The outcome for the event "np3 which did not inject his dose" was not reported. Investigation results: name: mixtard® 30 penfill® 3 ml 100iu/ml. Batch gr79849. The product was not returned for examination. A reference sample was examined macroscopically and microscopically. Parameters identity, assay and degradation were also performed. The reference sample was found to be normal. The results were found to comply with specifications. During investigation it has not been possible to detect any irregularities related to the complaint on a reference sample of the batch in question. Name: novopen® 3; batch tug0329; the product was not returned for examination. The batch documentation was reviewed with focus on efficacy and delivery. No abnormalities relating to the observed problem were found. Nothing abnormal was found. Name: novopen® 3; batch yug0804; the product was not returned for examination. The batch documentation was reviewed with focus on efficacy and delivery. No abnormalities relating to the observed problem were found. Nothing abnormal was found. Manufacturer comment: 06-nov-2018: as the device (novopen 3) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device 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 (b)(4). In this case the reported events retinal haemorrhage, blindness are considered unlisted and the event of blood glucose increased is considered listed, events of retinal haemorrhage leading to blindness requiring an eye surgery are not uncommon in patients with underlying uncontrolled diabetes mellitus. Blindness may be due to the underlying diabetic complications such as diabetic retinopathy. However more details are needed for the proper medical evaluation. This single case does not change the safety profile of mixtard. Reporter comment: patient is not suffering from any other chronic diseases. Evaluation summary: investigation results: name: novopen® 3, batch tug0329. The product was not returned for examination. The batch documentation was reviewed with focus on efficacy and delivery. No abnormalities relating to the observed problem were found. Nothing abnormal was found.
 
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Brand NameNOVOPEN 3
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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key8048221
MDR Text Key126512796
Report Number9681821-2018-00073
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
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 10/09/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2015
Device Model NumberN/A
Device Catalogue Number185290
Device Lot NumberYUG0804
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2010
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: 11/07/2018 Patient Sequence Number: 1
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