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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 Excess Flow or Over-Infusion (1311)
Patient Problem Hypoglycemia (1912)
Event Date 08/01/2021
Event Type  Injury  
Event Description
Event verbatim [preferred term] (related symptoms if any separated by commas) the pen inject extra dose [incorrect dose administered by device] hypoglycemia [hypoglycaemia] case description: this serious spontaneous case from (b)(6) was reported by a consumer as "the pen inject extra dose(incorrect dose administered by device)" beginning on (b)(6)2021, "hypoglycemia(hypoglycemia)" beginning on (b)(6) 2021, and concerned a (b)(6) female patient who was treated with novopen 4 (insulin delivery device) from unknown start date for "type 1 diabetes mellitus~", , actrapid penfill (insulin human) solution for injection, 100 iu/ml, dose, frequency & route used- 18 iu, qd(6u morning - 8u lunch - 4u evening), subcutaneous from (b)(6) 2021 for "type 1 diabetes mellitus", patient's height: 154 cm. Patient's weight: (b)(6). Patient's bmi: 16. 02293810. Dosage regimens: novopen 4: not reported actrapid penfill: (b)(6) 2021; current condition: type 1 diabetes mellitus(started from 1 year and half), gout. Concomitant products included - retard(allergens nos), ciprocin [ciprofloxacin hydrochloride](ciprofloxacin hydrochloride), urosolvine [atropine sulfate;colchicine;piperazine citrate](atropine sulfate, colchicine, piperazine citrate) ongoing, toujeo pen (non codable) on a unspecified date of (b)(6) 2021, the patient face a problem in her novopen 4 by confirming the pen inject extra dose and this caused hypoglycemia, and the patients random blood sugar was ranged from 30-53 mg/dl and her hba1c was 10% from 2 week ( before using actarpid ) batch numbers: novopen 4: hvgp048, actrapid penfill: kr76f22. Action taken to novopen 4 was reported as product discontinued due to ae. Action taken to actrapid penfill was reported as product discontinued due to ae. The outcome for the event "the pen inject extra dose(incorrect dose administered by device)" was not reported. On (b)(6) 2021 the outcome for the event "hypoglycemia(hypoglycemia)" was recovered. Preliminary manufacturer's comment: 25-aug-2021: the suspected device novopen 4 has not been returned to novo nordisk for evaluation. No conclusion is reached. Company comment: hypoglycaemia is assessed as listed according to the novo nordisk current ccds in actrapid. Considering the pharmacological property of actrapid, hypoglycaemia is assessed as related to actrapid. This single case report is not considered to change the current knowledge of the safety profile of hypoglycaemia.
 
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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 Key12414103
MDR Text Key281013598
Report Number9681821-2021-00051
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeEG
PMA/PMN Number
20-986
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation
Type of Report Initial
Report Date 08/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2021
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 NumberHVGP048
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/02/2021 Patient Sequence Number: 1
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