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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 Problem Mechanical Jam (2983)
Patient Problem Hypoglycemia (1912)
Event Date 11/23/2021
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) patient's blood glucose decreased [blood glucose decreased] patient received three injections subcutaneously at the same time (first two injections didn't completed) [extra dose administered] pushing rod of the syringe could not move the liquid medicine into the needle [device mechanical issue] case description: this serious spontaneous case from (b)(6) was reported by a health care professional nos as "patient's blood glucose decreased(blood glucose decreased)" beginning on (b)(6) 2021, "patient received three injections subcutaneously at the same time (first two injections didn't completed)(extra dose administered)" beginning on (b)(6) 2021, "pushing rod of the syringe could not move the liquid medicine into the needle(device mechanical jam)" beginning on (b)(6) 2021, and concerned a (b)(6) years old male patient who was treated with novopen 4 (insulin delivery device) from (b)(6) 2021 for "diabetes mellitus". Patient's height, weight and body mass index (bmi) were not reported. Dosage regimens: novopen 4: (b)(6) 2021 to not reported; current condition: diabetes mellitus (type and duration not reported). On (b)(6) 2021, when the patient adjusted the scale for subcutaneous injection at home, the patient found that the pushing rod of the syringe could not move, so the patient pulled out the syringe and observed that there was no abnormality in the appearance. The patient still cannot completed second subcutaneous injection (the first two injections didn't completed) therefore patient went to community clinic and changed a new injection pen to complete the subcutaneous injection under the condition of eliminating that the injection needle was blocked. The patient received three injections subcutaneously at the same time, leaded patient's blood glucose decreased (severe injury). Batch numbers: novopen 4: kvgy715-1. Action taken to novopen 4 was not reported. The outcome for the event "patient's blood glucose decreased (blood glucose decreased)" was not reported. The outcome for the event "patient received three injections subcutaneously at the same time (first two injections didn't completed) (extra dose administered)" was not reported. The outcome for the event "pushing rod of the syringe could not move the liquid medicine into the needle (device mechanical jam)" was not reported. References included: reference type: e2b authority number. Reference id#: (b)(6). Reference notes: nmpa (national medical products administration), (b)(6).
 
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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 Key13008963
MDR Text Key282264131
Report Number9681821-2021-00091
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number185490
Device Lot NumberKVGY715-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2020
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: 12/15/2021 Patient Sequence Number: 1
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