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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4 INSULIN DELIVERY DEVICE

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NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4 INSULIN DELIVERY DEVICE Back to Search Results
Model Number N/A
Device Problems Defective Component (2292); Failure to Deliver (2338)
Patient Problem Hyperglycemia (1905)
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas). Elevated blood glucose value [blood glucose increased]. Piston rod did not move forward, no insulin was delivered [device malfunction]. Piston rod did not move forward, no insulin was delivered [device failure]. Case description: this serious spontaneous case from (b)(6) was reported by a diabetes nurse specialist as "elevated blood glucose value(blood glucose increased)" with an unspecified onset date, "piston rod did not move forward, no insulin was delivered (device component malfunction)" with an unspecified onset date, "piston rod did not move forward, no insulin was delivered (device failure)" with an unspecified onset date, and concerned a female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "device therapy", patient's height, weight and body mass index were not reported. Medical history was not provided. On an unknown date, it was reported that as the piston rod of novopen 4 did not move forward, no insulin was delivered and patient had a blood glucose value of 539 mg/dl at lunch time. According to patient pen was approximately 10 years old. Batch numbers: novopen 4: dug0265. Action taken to novopen 4 was not reported. The outcome for the event "elevated blood glucose value(blood glucose increased)" was not reported. The outcome for the event "piston rod did not move forward, no insulin was delivered (device component malfunction)" was not reported. The outcome for the event "piston rod did not move forward, no insulin was delivered (device failure)" was not reported.
 
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Brand NameNOVOPEN 4
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 3400
Manufacturer Contact
p.o. box 846
plainsboro,, NJ 08536
8007276500
MDR Report Key12518018
MDR Text Key272869799
Report Number9681821-2021-00056
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/19/2019
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberDUG0265
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2014
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: 09/23/2021 Patient Sequence Number: 1
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