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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S NOVOPEN 5 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Defective Component (2292)
Patient Problem Hyperglycemia (1905)
Event Type  malfunction  
Event Description
(related symptoms if any separated by commas). Piston rod cannot be moved forward [device issue]. Increased blood glucose values [blood glucose increased]. Case description: this serious spontaneous case from (b)(6) was reported by a pharmacist as "increased blood glucose values (blood glucose increased)" with an unspecified onset date, "piston rod cannot be moved forward (device component defective)" with an unspecified onset date, and concerned a (b)(6) year-old female patient who was treated with novopen 5 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus". The patient's height, weight and body mass index were not reported. Current condition: type 1 diabetes mellitus (duration : not reported). It was reported that on an unknown date, patient had increased blood glucose values of > 600 mg/dl during use of novopen 5. Piston rod cannot be moved forward but insulin was delivered. Batch numbers: novopen 5: asku. The outcome for the event "increased blood glucose values(blood glucose increased)" was not reported. The outcome for the event "piston rod cannot be moved forward(device component defective)" was not reported. In order to protect the safety of patient it will, in rare cases, be required to disassemble the medical device immediately in a way where it is not subsequently possible to reassemble it (e. G. Destructive testing or altering of the medical device). The disassembled medical device will be stored with the same retention period as other complaint samples. This report is for a foreign device that is assessed as "similar" to us marketed novopen echo. (b)(4). References included: reference type: e2b company number, reference id#: (b)(4); reference type: e2b report duplicate, (b)(4).
 
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Brand NameNOVOPEN 5
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 Key10518140
MDR Text Key245925720
Report Number9681821-2020-00038
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K123766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/24/2020
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: 09/10/2020 Patient Sequence Number: 1
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