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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 Difficult to Advance (2920)
Patient Problems Pain (1994); Reaction, Injection Site (2442)
Event Date 05/10/2020
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) push button hard to depress [device malfunction] injection site pain [injection site pain] case description: this serious spontaneous regulatory authority case received via nmpa (national medical products administration), chn from (b)(6). Was reported by a health care professional as "push button hard to depress(device component malfunction)" beginning on (b)(6) 2020, "injection site pain(injection site pain)" beginning on (b)(6) 2020, and concerned a (b)(6)-year-old female patient who was treated with novopen 4 (insulin delivery device) from (b)(6) 2020 for "diabetes mellitus". The patient's height, weight and body mass index were not reported. Dosage regimens: novopen 4: (b)(6) 2020 to not reported. Current condition: diabetes mellitus (type and duration not reported). Historical condition: hyperglycemia. It was reported that the patient was given long-term insulin injection due to years of history of hyperglycemia. On (b)(6) 2020, the patient used novopen 4 to inject insulin and found the push button hard to depress, the same situation happened when the patient asked her family for help. The patient experienced injection site pain also. Novopen was changed with new pen. Batch numbers: novopen 4: unknown. Action taken to novopen 4 was reported as product discontinued due to adverse event (ae). The outcome for the event "push button hard to depress(device component malfunction)" was not reported. The outcome for the event "injection site pain(injection site pain)" was not reported. No further information available. References included: reference type: e2b report duplicate. Reference id#: (b)(6). Reference notes: nmpa (national medical products administration), chn.
 
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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
Manufacturer Contact
p.o. box 846
plainsboro, NJ 08536
8007276500
MDR Report Key10282807
MDR Text Key203281845
Report Number9681821-2020-00033
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
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: 07/16/2020 Patient Sequence Number: 1
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